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Neglected Disease Pipeline > Targets > Recombinant/purified
protein vaccines
Background
Overview | Existing Products | Get Involved
What are Recombinant/Purified Protein Vaccines?
Recombinant or purified protein vaccines consist of protein antigens that have either been produced in a heterologous expression
system (e.g., bacteria or yeast) or purified from large amounts of the pathogenic organism. The vaccinated person produces antibodies
to the protein antigen, thus protecting him/her from disease.
Overview
Recombinant/purified protein vaccines are based on the concept that humoral immune responses mounted to an infection are often
targeted toward specific localized regions on the surface of protein antigens known as epitopes. The recombinant proteins for
vaccination are produced by expressing these immunogenic proteins using heterologous expression systems. The immunogenic
protein antigens can also be purified from the infectious organism. Once purified, protein antigens, recombinant and endogenous, are
administered with an adjuvant to boost the immune response. Administering just the most immunogenic protein or proteins from an
infectious organisms as a vaccine produces a more targeted immune response. This strategy also eliminates the risk of active infection
that can occur with live attenuated vaccines or even inactivated vaccines where inactivation is incomplete.
Existing Products
There are a limited number of recombinant/purified protein vaccines currently in use. Examples of successful recombinant/purified
protein vaccines are listed here. The majority of on market vaccines using this strategy are related to protecting a person against the
damage caused by secreted toxins rather than protecting a person against infection by the bacterium or virus.
Vaccine
Description
Impact
Cholera
Recombinant cholera toxin B is a component of Dukoral, a
cholera vaccine that also contains inactivated whole bacteria.
Dukoral has limited efficacy and duration of immune response.
Interestingly, Dukoral provides some cross protection against
enterotoxigenic E. coli (ETEC) due to similarities between
ETEC and cholera toxins.
Cholera vaccines are not yet widely
available, so the true impact of these
vaccines has not been determined.
Diphtheria
Diphtheria vaccine is based on purified diphtheria toxin that is
chemically inactivated. The inactivated toxin is referred to as a
toxoid. As it is the toxin rather than the bacterium that causes
the majority of diphtheria symptoms, producing antibodies to
the toxin protects against symptomatic disease even though it
does not prevent infection with the bacteria.
Since the introduction of the combined
diphtheria, tetanus, pertussis vaccine
through the World Health Organization
(WHO) Expanded Program on
Immunization in 1974, reported
diphtheria cases dropped by more than
90%.
The number of countries providing
Hepatitis B
Tetanus
A recombinant protein vaccine against hepatitis B infection
has been available since 1981. The vaccine uses hepatitis B
surface antigen produced in yeast.
Similar to the diphtheria vaccine, the tetanus vaccine is based
on the use of inactivated tetanus toxin to produce antibodies
that neutralize the toxin even though they do not kill the
infectious bacteria.
hepatitis B vaccinations has increased
from 31 in 1992 to 164 in 2006. As the
health impact of hepatitis B is associated
with chronic infection, the health impact
of the vaccination has not been
extensively measured.
As mentioned above, the combined
diphtheria, tetanus, pertussis vaccine has
had a significant health impact. The focus
of tetanus vaccination is on the
prevention of mother to neonatal
transmission of the bacteria that cause
tetanus.
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changes, or corrections to the Global Health Primer website, please view our FAQs or contact us at [email protected].
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Pipeline & Analysis
Get Involved
PIPELINE
Product/Research
Program
Developers
AIDSVAX B/E
Armed Forces Research
Institute of Medical
Sciences, Thailand
Global Solutions for
Infectious Diseases
Henry M. Jackson
Foundation for the
Advancement of Military
Medicine
Mahidol University
Ministry of Public Health,
Thailand
National Institute of
Allergy and Infectious
Diseases
Royal Thai Army Medical
Department
The EMMES Corporation
Tripler Army Medical
Center
Walter Reed Army
Institute of Research
RTS,S/AS01
GlaxoSmithKline
Malaria Vaccine Initiative
Bilhvax
Eurogentec
French National Institute
of Health and Medical
Research
Institut Pasteur
HIV p17/p24:Ty-VLP
(Preventative)
GlaxoSmithKline
HIV p17/p24:Ty-VLP
(Theraputic)
GlaxoSmithKline
PvCSP/AS01
GlaxoSmithKline
Malaria Vaccine Initiative
Walter Reed Army
Institute of Research
AMA1-C1/Alhydrogel
National Institute of
Allergy and Infectious
Diseases
University of Oxford
GMZ2
African Malaria Network
Trust
Statens Serum Institut
Discovery
Pre-clinical
Phase I
Phase II
Phase III
Vakzine Projekt
Management GmbH
M72
Aeras Global TB Vaccine
Foundation
GlaxoSmithKline
South African
Tuberculosis Vaccine
Initiative
DEN1-80E
Merck & Co., Inc.
dmLT
National Institute of
Allergy and Infectious
Diseases
PATH
Tulane University
DCVax-001
Celldex Therapeutics
Inc.
Rockefeller University
EnvPro
National Institute of
Allergy and Infectious
Diseases
St. Jude Children's
Research Hospital
PEV301 & 302
Mymetics S.A.
Pevion Biotech Ltd.
Swiss Tropical and
Public Health Institute
BSAM-2/Alhydrogel
National Institute of
Allergy and Infectious
Diseases
EBA-175 RII-NG
Baylor College of
Medicine
National Institute of
Allergy and Infectious
Diseases
JAIVAC-1
Bharat Biotech
European Vaccine
Initiative
International Centre for
Genetic Engineering and
Biotechnology
Pneumo meningitis &
pneumonia in infants
(monovalent)
Sanofi Pasteur
IC47
Intercell AG
PATH
Sm14 (Schisto)
Brazillian Innovation
Agency
Oswaldo Cruz
Foundation
Aeras Global TB Vaccine
SSI/SP H4-IC31®
Foundation
Intercell AG
Sanofi Pasteur
South African
Tuberculosis Vaccine
Initiative
Statens Serum Institut
H1-CAF01
Statens Serum Institut
H1-IC31
Statens Serum Institut
SSI H56-IC31®
Aeras Global TB Vaccine
Foundation
Statens Serum Institut
Sm14 (Fascioliasis)
Brazilian Ministry of
Health
Oswaldo Cruz
Foundation
TAT vaccine
Instituto Superiore di
Sanita
South African AIDS
Vaccine Initiative
Subunit recombinant
antigen (domain III)
vaccine
Cuban Center for
Genetic Engineering and
Biotechnology
Pedro Kouri Tropical
Medicine Institute
LEISH-F3
Infectious Disease
Research Institute
PneuGEM
Mucosis B.V.
PATH
Radboud University
Nijmegen Medical
Centre
FTL-LTB chimera protein
Naval Medical Research
Center
Sanofi Pasteur
University of Colorado
LT/ST fusion proteins
International Enteric
Vaccine Consortium
PATH
Research Council of
Norway
EtpA glycoprotein
University of Tennesee
Multivalent protein
vaccine candidate
(PATH/St. Jude)
PATH
St. Jude Children's
Research Hospital
University of Adelaide
University of Alabama at
Birmingham
Human Hookworm
NaGST-1
Vaccine Initiative
Oswaldo Cruz
Foundation
Sabin Vaccine Institute
NaAPR-1
Human Hookworm
Vaccine Initiative
Oswaldo Cruz
Foundation
Sabin Vaccine Institute
PvRII
International Centre for
Genetic Engineering and
Biotechnology
Malaria Vaccine Initiative
AnAPN-1
Johns Hopkins
University Medical
School
Malaria Vaccine Initiative
Sabin Vaccine Institute
TSP2
Instituto Butantan
James Cook University
Oswaldo Cruz
Foundation
Sabin Vaccine Institute
Leprosy vaccine program
Infectious Disease
Research Institute
CelTOS + GLA-SE
Bill & Melinda Gates
Foundation
Infectious Disease
Research Institute
US Agency for
International
Development
Walter Reed Army
Institute of Research
AMA1-DiCo
Biomedical Primate
Research Centre
European Vaccine
Initiative
IMX-MSP4
Imaxio
University of Oxford
trypanosome vaccine
antibodies
iBIO
FB-1811
Folia Biotech
rSm-p80
Texas Tech University
Group-common
pneumococcal vaccine
GlaxoSmithKline
NasVax
rMOMP vaccine
National Institute of
Allergy and Infectious
Diseases
University of California,
Irvine
Novel T-cell antigen
vaccine
Children's Hospital
Boston
Genocea Biosciences
PATH
Pneumoccocal vaccine
adjuvant development
program
PATH
University of Glasgow
rWbGST
University of Illinois Chicago
Pfs48
Gennova
Biopharmaceuticals
Malaria Vaccine Initiative
Tulane University
Anti-L3 vaccine (NYBC)
New York Blood Center
Anti-L3 vaccine (LSTM)
Liverpool School of
Tropical Medicine
Mimopath-based
Shigellosis vaccine
Mucosis B.V.
PATH
Mimopath-based ETEC
vaccine
Mucosis B.V.
PATH
Chimigen malaria
vaccine
Paladin Biosciences
division of Paladin Labs
Inc.
Chimigen HIV vaccine
Paladin Biosciences
division of Paladin Labs
Inc.
AMA1
Malaria Vaccine Initiative
Walter and Elizabeth
Hall Institute of Medical
Research
Walter Reed Army
Institute of Research
PvDBII
International Centre for
Genetic Engineering and
Biotechnology
Malaria Vaccine Initiative
Traveler's diarrhea
vaccine
Intercell AG
On Hold
LEISH-F1 + MPL-SE
Infectious Disease
Research Institute
On Hold
LEISH-F2 + MPL-SE
Infectious Disease
Research Institute
On Hold
EP1043
National Institute of
Allergy and Infectious
Diseases
VaxOnco
On Hold
NaASP-2
Human Hookworm
Vaccine Initiative
Oswaldo Cruz
Foundation
Sabin Vaccine Institute
On Hold
FMP010
GlaxoSmithKline
US Agency for
International
Development
US Army Medical
Research and Materiel
Command
On Hold
rBCG30
University of California,
Los Angeles
On Hold
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ANALYSIS
Although there are a limited number of recombinant or purified protein vaccines currently in use, recombinant protein vaccines make
up the majority of products in development for neglected tropical diseases. The relative strengths, weaknesses, opportunities, and risks
for recombinant/purified protein vaccines for viral, bacterial, and parasitic diseases are summarized here.
Strengths
Weaknesses
Opportunities
AIDSVAX failed to show
efficacy in a clinical trial
among intravenous drug
users when used alone
Combination with other
vaccination technologies,
especially as part of
prime-boost regimens
Risks
Recombinant/purified protein: Viral diseases
Relevant neglected
tropical diseases:
HIV (AIDSVAX B/E,
phase III; multiple
additional products in
discovery through phase
II)
Dengue (DEN1-80E,
phase I)
Established method for
prevention of viral
infections based on
success of hepatitis B
vaccine
Other dengue vaccines
are in more advanced
stages of development
Mechanism of protection
from the phase III study
of AIDSVAX is unclear;
more information is
needed to determine if
recombinant protein
technology should be
pursued as part of future
HIV vaccine programs
AIDSVAX demonstrated
clinical efficacy (~30%
protection) in phase III in
combination with another
product
Recombinant/purified protein: Bacterial diseases
Relevant neglected
tropical diseases:
Cholera (component of
Dukoral, on market)
Partial efficacy has been
observed for the
recombinant cholera
toxin B component of
Dukoral
Tuberculosis (M72, phase
II; multiple additional
products in pre-clinical
and phase I)
Human clinical trial data
does not yet exist for the
effects of recombinant
protein vaccines for the
prevention of
tuberculosis
Combination with other
vaccination technologies,
especially as part of
prime-boost regimens
Current vaccines for
enteric bacterial
infections, such as
cholera and ETEC, and
tuberculosis are only
partially effective, so it is
unlikely a recombinant
protein vaccine will be
effective on its own
Combination with other
vaccination technologies
There are currently no
vaccines available for
ETEC (dmLT, phase I)
Recombinant/purified protein: Parasitic protozoan diseases
Relevant neglected
tropical diseases:
RTS,S vaccine
demonstrated clinical
RTS,S did not
demonstrate sterilizing
Malaria (RTS,S, phase III;
multiple products in
discovery through phase II
development)
efficacy for malaria
prevention (~30-50%)
and reduced disease
severity
Leishmaniasis (LEISH-F3,
pre-clinical; variation on
LEISH-F1 and -F2
vaccines previously in
phase II development)
immunity
Previous clinical trials of
leishmaniasis vaccines
focused on cutaneous
leishmaniasis, so
efficacy for prevention of
the more severe visceral
disease remains to be
determined
especially as part of
prime-boost regimens
There are currently no
vaccines for this group of
organisms, so successful
development may be
translatable to other
diseases caused by
parasitic protozoa
the prevention of
infection with parasitic
protozoa, so it is unclear
if vaccination will be
successful for prevention
More extensive studies
needed to understand if
partial protection
reduces severity of
disease if complete
sterilizing immunity is not
possible
Recombinant/purified protein: Parasitic helminth diseases
Relevant neglected
tropical diseases:
Schistosomiasis (Bilvax,
phase III; Sm14 phase I;
TSP 2, pre-clinical)
Hookworm (NaGST-1 and
NaAPR-1, pre-clinical)
Lymphatic filariasis
(rWbGST, discovery)
Because multicellular
helminthes are difficult to
culture, live attenuated
and inactivated vaccines
are impractical;
recombinant proteins
represent the most
advanced stage
alternative technology for
these organisms
Previous attempts at
vaccine development for
hookworm using larval
stage recombinant
proteins caused
unexpected allergic
reactions in patients with
previous exposure to
hookworm which may
limit protein antigen
choices to those of adult
stage worms
Combinations of
recombinant proteins for
a single organism or
across multiple
organisms to improve
immune response
Combination with mass
drug administration to
prevent reinfection
Studies are needed that
examine effects on
severity or decreases in
worm burden beyond
prevention of infection
Many helminthes can be
treated with inexpensive
drugs through mass drug
administration programs,
so it is unclear what role
vaccination will play in
control programs
There are currently no
vaccines for the
prevention of helminth
infections so it is unclear
if vaccination will be
successful for prevention
Get Involved
To learn how you can get involved in neglected disease drug, vaccine or diagnostic research and development, or to provide updates,
changes, or corrections to the Global Health Primer website, please view our FAQs or contact us at [email protected].
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Tools
Get Involved
Recombinant and purified protein vaccines benefit from extensive resources from the biochemistry community for the production and
purification of proteins including:
• Multiple heterologous recombinant protein expression systems (e.g., bacteria, yeast, mammalian cells, cell free extracts)
• Multiple protein tagging and purification methods (e.g., epitope tags, affinity tags, cleavable tags)
• Automated protein purification systems (e.g., variety of fast protein liquid chromatography systems using gel filtration,
anion/cation exchange, or hydrophobic properties
There are numerous publications and manuals with detailed protocols for protein expression and purification especially from vendors
who sell protein purification equipment and accessories.1-3
More information on the availability of tools for protein antigen identification and expression for specific neglected diseases is available
in each of the specific disease profiles.
References
1. Walker JM (ed.) The Protein Protocols Handbook, 3rd edition, 2009.
2. Promega Protocols & Applications Guide: Protein purification and analysis, available here.
3. Elsevier scientific journal: Protein Expression and Purification, available here.
Get Involved
To learn how you can get involved in neglected disease drug, vaccine or diagnostic research and development, or to provide updates,
changes, or corrections to the Global Health Primer website, please view our FAQs or contact us at [email protected].
Product Details
AIDSVAX B/E
Synonyms:
AIDSVAX B/E
Disease:
Human Immunodeficiency Virus (HIV)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, boost, clades B and E
Mechanism of Action:
MN gp120, A244 gp120
Product Type:
Vaccine
Molecule Class:
Administration Route:
IM
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
Currently in Phase III with ALVAC-HIV (vCP1521) but originally entered
Phase III alone in 1999.
NCT00006327
NCT00001096
NCT00002402
NCT00337181
NCT00223080
NCT00000879
NCT00000871
NCT00011037
19843557
AMA1
Synonyms:
AMA1
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
AMA1-C1/Alhydrogel
Synonyms:
AMA1-C1/Alhydrogel
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, P. falciparum
erythrocytic stage
Mechanism of Action:
Mixture of two recombinant synthetic AMA1
proteins from two Plasmodium falciparum
strains
Notes:
Product Type:
Vaccine
Molecule Class:
PRV Elegible?
Yes
Administration Route:
IM
Clinical Trials:
Publications:
NCT00984763
NCT00427167
NCT00344539
NCT00414336
NCT00740090
AMA1-DiCo
Synonyms:
AMA1-DiCo
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Clinical
Trials:
Notes:
Publications:
A diversity covering approach to increase immunogenicity to multiple AMA-1 alleles.
For more information on this product, see European Vaccine Initiative.
AnAPN-1
Synonyms:
AnAPN-1
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Transmission blocking
Mechanism of Action:
AnAPN-1
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
Anti-L3 vaccine (LSTM)
Synonyms:
Anti-L3 vaccine (LSTM)
Disease:
Onchocerciasis (River Blindness)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
19901988
Anti-L3 vaccine (NYBC)
Synonyms:
Anti-L3 vaccine (NYBC)
Disease:
Onchocerciasis (River Blindness)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
Bilhvax
Synonyms:
Bilhvax
Sh28GST
Disease:
Schistosomiasis
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Prevention of reinfection after
concurrent treatment, S. haematobium
Mechanism of Action:
Product Type:
Vaccine
Administration Route:
SC
Molecule Class:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
NCT00870649
12753436
BSAM-2/Alhydrogel
Synonyms:
BSAM-2/Alhydrogel
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Preventive, P. falciparum
erythrocytic stage
Product Type:
Vaccine
MSP-1 and AMA-1
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
NCT00889616
CelTOS + GLA-SE
Synonyms:
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
antigen + adjuvant
Product Type:
Vaccine
Molecule Class:
PRV Elegible?
Yes
Notes:
Administration Route:
Clinical Trials:
Publications:
Chimigen HIV vaccine
Synonyms:
Chimigen HIV vaccine
Disease:
Human Immunodeficiency Virus (HIV)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
Dendritic cell-receptor targeted approach.
Chimigen malaria vaccine
Synonyms:
Chimigen malaria vaccine
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive
Mechanism of Action:
CSP, AMA, LSA, and MSP
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
Combines four malaria antigens and targets dendritic cells.
DCVax-001
Synonyms:
DCVax-001
Disease:
Human Immunodeficiency Virus (HIV)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
NCT01127464
DEN1-80E
Synonyms:
DEN1-80E
HBV-001 D1
Recombinant E subunit vaccine
Disease:
Dengue fever
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, serotype 1
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
NCT00936429
20097152
dmLT
Synonyms:
dmLT
Disease:
Enterotoxigenic E. coli (ETEC)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Anti-toxin, LT
Mechanism of Action:
Molecule Class:
Product Type:
Vaccine
Administration Route:
Oral
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
NCT01147445
EBA-175 RII-NG
Synonyms:
EBA-175 RII-NG
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, P. falciparum
erythrocytic stage
Mechanism of Action:
EBA
Product Type:
Vaccine
Molecule Class:
Administration Route:
IM
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
NCT00347555
NCT01026246
16735084
20702657
EnvPro
Synonyms:
EnvPro
Disease:
Human Immunodeficiency Virus (HIV)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
IM
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
NCT00076947
EP1043
Synonyms:
EP1043
Disease:
Human Immunodeficiency Virus (HIV)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Preventive
pol, vpu, gag
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Safety and tolerability demonstrated in Phase I trial in combination with
EP1090 but only weak immunogenicity observed.
NCT00141024
Publications:
EtpA glycoprotein
Synonyms:
EtpA glycoprotein
Disease:
Enterotoxigenic E. coli (ETEC)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
FB-1811
Synonyms:
FB-1811
Disease:
Typhoid fever
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
FMP010
Synonyms:
FMP010
Plasmodium falciparum Malaria
protein 010
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
MSP-1
PRV Elegible?
Yes
Notes:
Clinical Trials:
Administration Route:
Publications:
NCT00666380
NCT00317473
FTL-LTB chimera protein
Synonyms:
FTL-LTB chimera protein
Disease:
Enterotoxigenic E. coli (ETEC)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
GMZ2
Synonyms:
GMZ2
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, P. falciparum
erythrocytic stage
Mechanism of Action:
GLURP and MSP3
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
NCT00397449
NCT00424944
NCT00703066
20009515
Group-common pneumococcal vaccine
Synonyms:
Group-common pneumococcal
vaccine
Disease:
Pneumococcal disease
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive
Mechanism of Action:
Product Type:
Molecule Class:
Administration Route:
Vaccine
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
H1-CAF01
Synonyms:
H1-CAF01
Ag85B-ESAT-6/CAF01
Disease:
Tuberculosis (TB)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, boost
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
NCT00922363
H1-IC31
Synonyms:
H1-IC31
Ag85B-ESAT-6/IC31
Disease:
Tuberculosis (TB)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, boost
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
NCT01049282
20488515
20226890
HIV p17/p24:Ty-VLP (Preventative)
Synonyms:
HIV p17/p24:Ty-VLP (Preventative)
HIV vaccine 732461
Disease:
Human Immunodeficiency Virus
(HIV)
Specific Indication:
Preventive
Target/Technology:
Recombinant/purified protein vaccines
Mechanism of Action:
Molecule Class:
Administration Route:
IM
Product Type:
Vaccine
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
NCT00001053
NCT00434512
NCT00972725
HIV p17/p24:Ty-VLP (Theraputic)
Synonyms:
HIV p17/p24:Ty-VLP (Theraputic)
HIV vaccine 732462
Disease:
Human Immunodeficiency Virus
(HIV)
Target/Technology:
Recombinant/purified protein vaccines
Mechanism of Action:
Specific Indication:
Therapeutic
Molecule Class:
Product Type:
Administration Route:
IM
Vaccine
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
NCT00814762
NCT01092611
NCT01218113
IC47
Synonyms:
IC47
Disease:
Pneumococcal disease
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
IM
PRV Elegible?
No
Notes:
Clinical Trials:
NCT00873431
IMX-MSP4
Publications:
Synonyms:
IMX-MSP4
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
JAIVAC-1
Synonyms:
JAIVAC-1
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, P. falciparum
erythrocytic stage
Mechanism of Action:
rPfMSP-119 and rPfEBA175
Molecule Class:
Product Type:
Vaccine
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
20009515
LEISH-F1 + MPL-SE
Synonyms:
LEISH-F1 + MPL-SE
LEISH-111f + MPL-SE
Disease:
Leishmaniasis
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive and therapeutic, Visceral
leishmaniasis (VL)
Mechanism of Action:
Product Type:
Vaccine
Administration Route:
Molecule Class:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Replaced by improved product LEISH-F2.
NCT00486382
NCT00121849
NCT00111553
NCT00111514
NCT00121862
Publications:
LEISH-F2 + MPL-SE
Synonyms:
LEISH-F2 + MPL-SE
Disease:
Leishmaniasis
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive and therapeutic, Visceral
leishmaniasis (VL)
Mechanism of Action:
Product Type:
Vaccine
Administration Route:
Molecule Class:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Replaced by improved product, LEISH-F3.
NCT01011309
NCT00982774
Publications:
LEISH-F3
Synonyms:
LEISH-F3
Disease:
Leishmaniasis
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, Visceral leishmaniasis
(VL)
Mechanism of Action:
Product Type:
Vaccine
Administration Route:
Molecule Class:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
Leprosy vaccine program
Synonyms:
Leprosy vaccine program
Disease:
Leprosy
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
LT/ST fusion proteins
Synonyms:
LT/ST fusion proteins
Disease:
Enterotoxigenic E. coli (ETEC)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
M72
Synonyms:
M72
Disease:
Tuberculosis (TB)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, boost
Mechanism of Action:
Molecule Class:
Product Type:
Vaccine
Administration Route:
IM
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
More information on this product is available from AERAS.
NCT00600782
NCT00621322
19188599
Mimopath-based ETEC vaccine
Synonyms:
Mimopath-based ETEC vaccine
Disease:
Enterotoxigenic E. coli (ETEC)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
PRV Elegible?
No
Notes:
Recombinant protein carried by bacterium-like particles (BLPs).
Mimopath-based Shigellosis vaccine
Administration Route:
Oral
Clinical Trials:
Publications:
Synonyms:
Mimopath-based Shigellosis vaccine
Disease:
Shigellosis
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
PRV Elegible?
No
Notes:
Administration Route:
Oral
Clinical Trials:
Publications:
Recombinant protein carried by bacterium-like particles (BLPs).
Multivalent protein vaccine candidate (PATH/St. Jude)
Synonyms:
Multivalent protein vaccine
candidate (PATH/St. Jude)
Disease:
Pneumococcal disease
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
NaAPR-1
Synonyms:
NaAPR-1
Disease:
Soil-Transmitted Helminths: Hookworm
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, N. americanus
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
20948553
NaASP-2
Synonyms:
NaASP-2
Disease:
Soil-Transmitted Helminths: Hookworm
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, N. americanus
Product Type:
Vaccine
Mechanism of Action:
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
Discontinued during Phase I trial in Brazil (2007-2008) due to allergic
reaction in patients from endemic areas.
NCT00120081
NCT00473967
20948553
NaGST-1
Synonyms:
NaGST-1
Disease:
Soil-Transmitted Helminths: Hookworm
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, N. americanus
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
20948553
Novel T-cell antigen vaccine
Synonyms:
Novel T-cell antigen vaccine
Disease:
Pneumococcal disease
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
PEV301 & 302
Synonyms:
PEV301 & 302
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Preventive, P. falciparum
pre-erythrocytic and erythrocytic
stages
AMA-1 and CSP delivered in virosomes
Product Type:
Vaccine
Administration Route:
Molecule Class:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
Previously evaluated as PEV3A.
NCT00513669
NCT00408668
18231580
Pfs48
Synonyms:
Pfs48
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Transmission blocking
Mechanism of Action:
CH-rPfs48/45
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
19623257
PneuGEM
Synonyms:
PneuGEM
Multivalent protein vaccine candidate
(PATH/Mucosis)
Disease:
Pneumococcal disease
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
Intranasal
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
Recombinant protein carried by bacterium-like particles (BLPs).
Pneumo meningitis & pneumonia in infants (monovalent)
Synonyms:
Pneumo meningitis &
Disease:
Pneumococcal disease
Target/Technology:
Recombinant/purified protein vaccines
pneumonia in infants
(monovalent)
Specific Indication:
Preventive
Mechanism of Action:
Molecule Class:
Product Type:
Vaccine
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
Pneumoccocal vaccine adjuvant development program
Synonyms:
Pneumoccocal vaccine adjuvant
development program
Disease:
Pneumococcal disease
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
PvCSP/AS01
Synonyms:
PvCSP/AS01
VMP001/AS01B
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, P. vivax
pre-erythrocytic stage
Mechanism of Action:
Product Type:
Vaccine
Administration Route:
IM
Molecule Class:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
NCT01157897
PvDBII
Synonyms:
PvDBII
P. vivax duffy binding protein II
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
P.vivax
Mechanism of Action:
Molecule Class:
Product Type:
Vaccine
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
PvRII
Synonyms:
PvRII
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, P. vivax
erythrocytic stage
Mechanism of Action:
DBP
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
rBCG30
Synonyms:
rBCG30
Disease:
Tuberculosis (TB)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
rMOMP vaccine
Synonyms:
rMOMP vaccine
Disease:
Trachoma
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
recombinant prime + protein subunit boost
Product Type:
Vaccine
PRV Elegible?
Molecule Class:
Administration Route:
Yes
Notes:
Clinical Trials:
Publications:
rSm-p80
Synonyms:
rSm-p80
Disease:
Schistosomiasis
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, S. mansoni
Mechanism of Action:
Product Type:
Vaccine
PRV Elegible?
Yes
Notes:
Clinical Trials:
Molecule Class:
In prime-boost combination with Sm-p80 DNA
vaccines.
Administration Route:
Publications:
19809833
21277404
RTS,S/AS01
Synonyms:
RTS,S/AS01
Mosquirix
GSK malaria vaccine 257049
Disease:
Malaria
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, P. falciparum
pre-erythrocytic stage
Mechanism of Action:
PfCSP protein fused to HBsAG (S) antigen that can
self assemble into viral particles
Product Type:
Vaccine
Molecule Class:
PRV Elegible?
Yes
Administration Route:
IM
Notes:
Clinical Trials:
Publications:
In phase III alone and phase II in prime-boost combination with
Ad35.CS.01.
NCT00866619
NCT00436007
NCT01148459
NCT00197028
NCT01366534
NCT01231503
NCT01345240
NCT00323622
NCT00443131
NCT01323972
NCT00289185
NCT00307021
NCT00360230
20553771
21443960
NCT00380393
rWbGST
Synonyms:
rWbGST
Disease:
Lymphatic filariasis (LF)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Wuchereria bancrofti
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
19513102
Sm14 (Fascioliasis)
Synonyms:
Sm14 (Fascioliasis)
Disease:
Fascioliasis
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
18834847
Sm14 (Schisto)
Synonyms:
Sm14 (Schisto)
Disease:
Schistosomiasis
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, S. mansoni with some
Fasciola hepatica cross protection
Mechanism of Action:
Product Type:
Vaccine
Administration Route:
Molecule Class:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
NCT01154049
20948553
18834847
SSI H56-IC31®
Synonyms:
SSI H56-IC31®
Ag85B-ESAT-6-Rv2660
Disease:
Tuberculosis (TB)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Therapeutic, boost
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
More information on this product is available from AERAS.
Publications:
21258338
SSI/SP H4-IC31®
Synonyms:
SSI/SP H4-IC31®
SSI HyVac4/AERAS-404
Disease:
Tuberculosis (TB)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, boost
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
More information on this product is available from AERAS.
Publications:
19896449
16714570
Subunit recombinant antigen (domain III) vaccine
Synonyms:
Subunit recombinant antigen
(domain III) vaccine
Disease:
Dengue fever
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive
Mechanism of Action:
Chimeric domain III protein fused to p64k of Neisseria
meningitidis
Product Type:
Vaccine
PRV Elegible?
No
Molecule Class:
Administration Route:
Notes:
Clinical Trials:
Publications:
21079655
TAT vaccine
Synonyms:
TAT vaccine
Italian AIDS vaccine
Disease:
Human Immunodeficiency Virus (HIV)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
inhibits HIV's TAT expression to repress viral
production
Product Type:
Vaccine
Molecule Class:
PRV Elegible?
No
Administration Route:
Notes:
Clinical Trials:
An ongoing trial in Italy is testing the efficacy of a prime boost TAT and Env
vaccine. See The Instituto Superiore di Sanita's page about their HIV vaccine.
NCT00529698
NCT00751595
Publications:
Traveler's diarrhea vaccine
Synonyms:
Traveler's diarrhea vaccine
Disease:
Enterotoxigenic E. coli (ETEC)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, developed for use in
travelers
Mechanism of Action:
Product Type:
Vaccine
Administration Route:
Transcutaneous
Molecule Class:
PRV Elegible?
No
Notes:
Clinical Trials:
Publications:
NCT00993681
NCT01040325
NCT00516659
trypanosome vaccine antibodies
Synonyms:
trypanosome vaccine
antibodies
Disease:
Human African Trypanosomiasis (HAT)
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
PRV Elegible?
Yes
Administration Route:
Notes:
Clinical Trials:
Publications:
TSP2
Synonyms:
TSP2
Disease:
Schistosomiasis
Target/Technology:
Recombinant/purified protein vaccines
Specific Indication:
Preventive, S. mansoni
Mechanism of Action:
Product Type:
Vaccine
Molecule Class:
Administration Route:
PRV Elegible?
Yes
Notes:
Clinical Trials:
Publications:
20948553