Trial reportPLoS neglected tropical diseases2016
Phase 1/2a Trial of Plasmodium vivax Malaria Vaccine Candidate VMP001/AS01B in Malaria-Naive Adults: Safety, Immunogenicity, and Efficacy.
Trial report in PLoS neglected tropical diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
73 citing papers in PubMed, 1 synthesis or guideline pooled it, 130 citations in OpenAlex.
- Reproducibility of malaria sporozoite challenge model in humans for evaluating efficacy of vaccines and drugs: a systematic review.BMC infectious diseases · 2021Pooled it
- Randomized clinical trial to assess the protective efficacy of a Plasmodium vivax CS synthetic vaccine.Nature communications · 2022Trial
- Efficacy and Response of R21/Matrix-M in Malaria Vaccine: A Systematic Review and Meta-Analysis of Clinical Trials.Vaccines · 2026Review
- Proteome-wide characterization of Plasmodium vivax antigens using a high-density peptide array.PLoS pathogens · 2026Article
- Zoonotic Parasite Nanovaccines: Progress, Challenges, and Future Perspectives.Integrative zoology · 2026Review
- Malaria serology for surveillance, insights into immunity, and vaccine development.Infection and immunity · 2026Review
- The Evolving Landscape of Malaria Prevention Strategies: A Review of Recent Developments.Pathogens (Basel, Switzerland) · 2026Review
- mRNA-LNP vaccine encoding theMolecular therapy. Nucleic acids · 2025Article
- Controlled human malaria infection studies: insights into recent advances and key immunological and ethical implementation lessons.Frontiers in immunology · 2025Review
- Plasmodium vivax circumsporozoite surface protein (PvCSP) as a vaccine candidate: a brief review.Revista do Instituto de Medicina Tropical de Sao Paulo · 2025Review
- Malaria vaccines: a new era of prevention and control.Nature reviews. Microbiology · 2024Review
- Development and longevity of naturally acquired antibody and memory B cell responses against Plasmodium vivax infection.PLoS neglected tropical diseases · 2024Review
- Polarization toward Tfh2 cell involved in development of MBC and antibody responses against Plasmodium vivax infection.PLoS neglected tropical diseases · 2024Article
- Vaccines and monoclonal antibodies: new tools for malaria control.Clinical microbiology reviews · 2024Review
- Evaluation of naturally acquired immune responses against novel pre-erythrocytic Plasmodium vivax proteins in a low endemic malaria population located in the Peruvian Amazon Basin.Malaria journal · 2024Article
- Superior protection in a relapsing Plasmodium cynomolgi rhesus macaque model by a chemoprophylaxis with sporozoite immunization regimen with atovaquone-proguanil followed by primaquine.Malaria journal · 2024Article
- Review
- Profiling the antibody response of humans protected by immunization with Plasmodium vivax radiation-attenuated sporozoites.Scientific reports · 2024Article
- Naturally acquired antibodies against Plasmodium vivax pre-erythrocytic stage vaccine antigens inhibit sporozoite invasion of human hepatocytes in vitro.Scientific reports · 2024Article
- Longitudinal analysis of antibody responses to Plasmodium vivax sporozoite antigens following natural infection.PLoS neglected tropical diseases · 2024Article
13 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA vaccine to prevent infection and disease caused by Plasmodium vivax is needed both to reduce the morbidity caused by this parasite and as a key component in efforts to eradicate malaria worldwide. Vivax malaria protein 1 (VMP001), a novel chimeric protein that incorporates the amino- and carboxy- terminal regions of the circumsporozoite protein (CSP) and a truncated repeat region that contains repeat sequences from both the VK210 (type 1) and the VK247 (type 2) parasites, was developed as a vaccine candidate for global use.
methodsWe conducted a first-in-human Phase 1 dose escalation vaccine study with controlled human malaria infection (CHMI) of VMP001 formulated in the GSK Adjuvant System AS01B. A total of 30 volunteers divided into 3 groups (10 per group) were given 3 intramuscular injections of 15 μg, 30 μg, or 60 μg respectively of VMP001, all formulated in 500 μL of AS01B at each immunization. All vaccinated volunteers participated in a P. vivax CHMI 14 days following the third immunization. Six non-vaccinated subjects served as infectivity controls.
resultsThe vaccine was shown to be well tolerated and immunogenic. All volunteers generated robust humoral and cellular immune responses to the vaccine antigen. Vaccination did not induce sterile protection; however, a small but significant delay in time to parasitemia was seen in 59% of vaccinated subjects compared to the control group. An association was identified between levels of anti-type 1 repeat antibodies and prepatent period. SIGNIFICANCE: This trial was the first to assess the efficacy of a P. vivax CSP vaccine candidate by CHMI. The association of type 1 repeat-specific antibody responses with delay in the prepatency period suggests that augmenting the immune responses to this domain may improve strain-specific vaccine efficacy. The availability of a P. vivax CHMI model will accelerate the process of P. vivax vaccine development, allowing better selection of candidate vaccines for advancement to field trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.