Clinical trials: Malaria Vaccines
Malaria
Efficacy, Safety and Immunogenicity Study of GlaxoSmithKline(GSK) Biologicals' Candidate Malaria Vaccine 257049 in the Sporozoite Challenge Model in Healthy Malaria-naïve Adults
This study is designed to evaluate safety, reactogenicity, immunogenicity, and efficacy of GSK Biological's malaria candidate vaccine 257049 administered as standard doses at 0 and 1 months and 1/5th standard dose at 7 months…
- Trial name
- NCT01857869
- Testing
- GSK257049 Dosage 1, GSK257049 Dosage 2, Sporozoite-infected mosquitoes challenge
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa
The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following…
- Trial name
- NCT02207816
- Testing
- Blood sampling, Malaria Vaccine 257049 (MALARIA-055 PRI), Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
- Where
- 3 sites in Burkina Faso, Kenya and 1 more
- Volunteers
- 3,084 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination.
- Trial name
- NCT03276962
- Testing
- RTS,S/AS01E (Full dose), RTS,S/AS01E (1/5th dose), Rabies vaccine
- Where
- 2 sites in Ghana, Kenya
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa
The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.
- Trial name
- NCT00866619
- Testing
- Malaria Vaccine 257049, Meningococcal C Conjugate Vaccine, Cell-culture rabies vaccine
- Where
- 10 sites in Burkina Faso, Gabon and 5 more
- Volunteers
- 15,459 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
The purpose of this study is to evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S/AS01E in healthy children aged 5-60 months in a malaria-endemic area.
- Trial name
- NCT07036159
- Testing
- RTS,S/AS01E vaccine
- Where
- 2 sites in Rwanda
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults
This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to…
- Trial name
- NCT01366534
- Testing
- Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01), GSK Biologicals' malaria vaccine 257049 (2 doses), GSK Biologicals' malaria vaccine 257049 (3 doses)
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring…
- Trial name
- NCT03503058
- Testing
- PfSPZ Vaccine, PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis, Normal Saline
- Where
- 2 sites in Indonesia
- Volunteers
- 345 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Study to Assess the Vaccine Efficacy Against Malaria Infection, in Children Immunized With the Primary and Yearly Booster of the RTS,S/AS01E Vaccine, as Part of Their Participation in the Malaria-094 (204889/NCT03276962) Study.
The aim of this study was to evaluate the effectiveness of the RTS,S/AS01E malaria vaccine against both clinical and asymptomatic malaria infections by detecting Plasmodium falciparum (P.
- Trial name
- NCT03281291
- Where
- 2 sites in Ghana, Kenya
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Africa
The aim of this epidemiology study is to characterize in a standardized way malaria transmission intensity at the clinical trial centers participating in study 110021 (NCT00866619).
- Trial name
- NCT01190202
- Testing
- Blood sampling, Assessment of body temperature
- Where
- 8 sites in Burkina Faso, Gabon and 4 more
- Volunteers
- 21,618 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model
The purpose of this study is to assess the safety, tolerability and immunogenicity of two dose levels (1x10^10 and 5x10^10 virus particles (vp)) of the adenovirus serotype (Ad) Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate…
- Trial name
- NCT01397227
- Testing
- Ad35.CS.01/Ad26.CS.01 low dose (1 x 10^10 vp), Ad 35.CS.01/Ad 26.CS.01 high dose (5 x 10^10 vp)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent…
- Trial name
- NCT02251704
- Testing
- Assessment of body temperature, Blood sampling
- Where
- 12 sites in Burkina Faso, Ghana and 4 more
- Volunteers
- 54,115 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria (Plasmodium Falciparum)
PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali
A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10^5 PfSPZ or placebo in healthy…
- Trial name
- NCT07675785
- Testing
- PfSPZ-LARC2 Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria Vaccine
Safety and Immunogenicity of the Recombinant Malaria Vaccines in Healthy Adults Aged 18-50 Years
This is a clinical trial in which healthy volunteers will receive one of three investigational malaria vaccines (LYB014, LYB017, and LYB027) administered in combination with the A02B adjuvant, or the A02B adjuvant alone as the…
- Trial name
- NCT07831226
- Testing
- LYB014 low dose, LYB014 high dose, LYB017 low dose
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Guangzhou Patronus Biotech Co., Ltd.
Malaria
Characterisation of the Immune Responses of 2 Experimental Malaria Vaccines
In this study, two experimental malaria vaccines (with adjuvants) are tested to evaluate and characterise how the vaccine exactly works on the immune system by comparing it to a control (without adjuvant).
- Trial name
- NCT00443131
- Testing
- GSK Malaria vaccine 257049
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This was a randomized, dose-escalation Phase I/IIa study to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P.
- Trial name
- NCT06069544
- Testing
- BNT165c, BNT165d
- Where
- 5 sites in United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Malaria Falciparum, Malaria Infection
Age De-escalation Safety Trial of PfSPZ-LARC2 Vaccine in Burkina Faso
This is a first-in-humans randomized, double-blind, placebo-controlled, age de-escalation Phase 1 trial of Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) malaria vaccine…
- Trial name
- NCT06652737
- Testing
- PfSPZ-LARC2 Vaccine
- Where
- Burkina Faso
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Regimen Optimization Trial of PfSPZ Vaccine in Equatorial Guinea
This is a phase 1, randomized regimen optimization study of PfSPZ Vaccine in healthy Equatoguinean volunteers to determine if a condensed, rapid immunization regimen is safe and efficacious.
- Trial name
- NCT03590340
- Testing
- PfSPZ Vaccine, Normal saline, PfSPZ Challenge (for CHMI)
- Where
- Equatorial Guinea
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria, Plasmodium Falciparum
Safety and Immunogenicity of Direct Venous Inoculation of a Radiation-attenuated PfSPZ Vaccine in Equatoguinean Adults
This is a single center, randomized, placebo-controlled, double-blind trial to assess the safety and immunogenicity of PfSPZ Vaccine administered by direct venous inoculation (DVI).
- Trial name
- NCT02418962
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Equatorial Guinea
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea.
This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in healthy Equatoguinean adults, adolescents, children and infants who receive doses of 0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via…
- Trial name
- NCT02859350
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (for CHMI), Normal Saline
- Where
- Equatorial Guinea
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria, Malaria,Falciparum
A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI
USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity, and vaccine…
- Trial name
- NCT05604521
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (7G8), Normal Saline
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.