Clinical trials: Malaria Vaccines
Malaria
Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine
The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of infants and children living in malaria endemic…
- Trial name
- NCT00323622
- Testing
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Engerix™-B, Hiberix®
- Where
- Mozambique
- Volunteers
- 1,737 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
A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals' Candidate Malaria Vaccine Administered to Previously Vaccinated Healthy Malaria-naïve Adults
MALARIA-092 (NCT03162614) study was designed to evaluate the efficacy, immunogenicity and safety of various dose schedules and formulations of GSK Biologicals' candidate malaria vaccine (RTS,S/AS01E) in healthy malaria-naïve…
- Trial name
- NCT03824236
- Testing
- RTS,S/AS01E (SB257049)
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
This is a randomized, double blind, placebo-controlled, single site, trial of a condensed regimen of PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity…
- Trial name
- NCT04966871
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (7G8) for CHMI, Normal Saline
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally…
- Trial name
- NCT03521973
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Gabon
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria (Plasmodium Falciparum)
Challenge Trial of PfSPZ-LARC2 Vaccine in Burkina Faso
This is a randomized, double-blind, placebo-controlled, Phase 1 trial of Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) malaria vaccine (Sanaria® PfSPZ-LARC2 Vaccine)…
- Trial name
- BFSPZL3 (NCT07730177)
- Testing
- PfSPZ-LARC2 Vaccine, PfSPZ Challenge, Normal Saline
- Where
- Burkina Faso
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
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
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Candidate Vaccines RTS,S/AS02D (0.5 mL Dose) and RTS,S/AS02A (0.25 mL Dose) Administered IM According to a 0, 1, 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique.
GSK Biologicals is developing in partnership with the Malaria Vaccine Initiative at PATH a candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children living in malaria endemic areas.
- Trial name
- NCT00197067
- Testing
- RTS,S/AS02D and RTS,S/AS02A
- Where
- Mozambique
- Volunteers
- 200 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
Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.
This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety.
- Trial name
- NCT00380393
- Testing
- GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine
- Where
- 2 sites in Kenya, Tanzania
- Volunteers
- 894 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.
The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6…
- Trial name
- NCT02699099
- Testing
- Vitamin A, Candidate Plasmodium falciparum malaria vaccine, MR-Vac
- Where
- 2 sites in Ghana
- Volunteers
- 699 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children.
- Trial name
- NCT00360230
- Testing
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Rabipur
- Where
- 2 sites in Ghana
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety, Tolerability and Efficacy of PfSPZ Vaccine in Healthy Children and Infants 5 Months - 9 Years Living in Kenya
This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy children aged 5 months through 9 years of age living within approximately 10 km of the study clinic(s) (Siaya County Referral Hospital, or…
- Trial name
- NCT02687373
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Kenya
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
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
Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen
This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first…
- Trial name
- NCT00436007
- Testing
- GSK 257049, Tritanrix™ HepB/Hib, Rouvax™
- Where
- 3 sites in Gabon, Ghana and 1 more
- Volunteers
- 511 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated…
- Trial name
- NCT01345240
- Testing
- GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Engerix-B™ vaccine, Infanrix/Hib™ vaccine
- Where
- 2 sites in Burkina Faso, Ghana
- Volunteers
- 705 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria,Falciparum
Study to Evaluate Safety, Immunogenicity and Efficacy of PfSPZ Vaccine in HIV Negative and HIV Positive Tanzanian Adults
This is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability of PfSPZ Vaccine administered as five doses of 9.0x10^5 PfSPZ or normal saline at 0, +2, +4, +6 and +28 days to healthy HIV negative…
- Trial name
- NCT03420053
- Testing
- PfSPZ Vaccine, PfSPZ Challenge
- Where
- Tanzania
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Prophylaxis Against Plasmodium Falciparum Malaria
A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720.
- Trial name
- NCT00284973
- Testing
- Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.
Malaria
Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy…
- Trial name
- NCT03162614
- Testing
- RTS,S/AS01E, RTS,S/AS01B, Sporozoite-infected mosquitoes challenge.
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Trial for Malaria Vaccine Candidate, PfPEBS (P. Falciparum Pre-Erythrocytic and Blood Stage)
This study intends to test the hypothesis that the malaria antigen PfPEBS, manufactured as a synthetic protein and adjuvanted with aluminium hydroxide will be well-tolerated and immunogenic (Phase 1), functionally active against…
- Trial name
- PEBS-POC1 (NCT01605786)
- Testing
- Lyophilised PEBS synthetic protein (PfPEBS), Rehydragel™ HPA
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Vac4All