Clinical trials: Malaria Vaccines
Malaria, Malaria Vaccines
A Study Assessing the Safety, Efficacy, and Impact of GlaxoSmithKline Biologicals' RTS, S/AS01E Malaria Vaccine in Young Children Across Sub-Saharan Africa
The RTS, S/AS01E vaccine was developed to protect children in sub-Saharan Africa from malaria as part of routine immunization programs. This study aims to check the vaccine's safety after it has been introduced.
- Trial name
- EPI-MAL-003 (NCT03855995)
- Testing
- Whole blood sample
- Where
- 6 sites in Ghana, Kenya and 1 more
- Volunteers
- 77,953 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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, 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
Sequential Optimization of Dose and Schedule of PfSPZ Vaccine
MAVACHE is a sequential dose and schedule optimization trial of intravenous immunization with PfSPZ Vaccine in 18 to 54 malaria-naïve, healthy adult volunteers receiving 9x10^5, 1.35x10^6, or 2.7x10^6 PfSPZ per dose and a total…
- Trial name
- NCT02704533
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (NF54), PfSPZ Challenge (7G8)
- Where
- Germany
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
PfSPZ Vaccine: Dose Optimization With Heterologous Challenge in Healthy Malaria-Naïve Adults
This is an open-label evaluation of the safety, tolerability, immunogenicity and efficacy of PfSPZ Vaccine administered by direct venous inoculation (DVI) in healthy, malaria-naïve adult subjects.
- Trial name
- NCT02601716
- Testing
- PfSPZ Vaccine, CHMI (7G8), CHMI (NF135.C10)
- Where
- 2 sites in United States
- Volunteers
- 92 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
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
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, Plasmodium Falciparum Malaria
Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults
This trial will evaluate whether relatively non-immune populations in endemic countries can effectively generate significant cellular and humoral immune responses that confer protection against P.
- Trial name
- NCT02132299
- Testing
- PfSPZ Vaccine, PfSPZ Challenge
- Where
- Tanzania
- Volunteers
- 67 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 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
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
Malaria
Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant
- Trial name
- NCT02013687
- Testing
- Pfs25 VLP- FhCMB
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Fraunhofer, Center for Molecular Biotechnology
Malaria
Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children
GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas.
- Trial name
- NCT00307021
- Testing
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
- Where
- Gabon
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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 Falciparum
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy…
- Trial name
- LARC-Tu (NCT06862453)
- Testing
- PfSPZ-LARC2 Vaccine, PfSPZ Challenge (NF54)
- Where
- Germany
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria, Malaria,Falciparum
PfSPZ Vaccine Trial in Malian Children
In this randomized, double-blind, placebo-controlled trial, 268 healthy Malian children aged 6-10 years, residing in Bancoumana and surrounding villages, will be administered three doses of 9.0x10^5 Pf sporozoites (PfSPZ) of…
- Trial name
- NCT04940130
- Testing
- Sanaria® PfSPZ Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 290 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
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
Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children
The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children
- Trial name
- NCT01148459
- Testing
- GSK Biological's Investigational Malaria Vaccine 257049, Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);, Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).
- Where
- 2 sites in Kenya
- Volunteers
- 200 people
- Sponsor
- GlaxoSmithKline