Trial reportPloS one2011
Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children.
Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00513669 (A Phase Ib Double-blind Randomized Placebo Controlled Age-deescalating Trial of Two Virosome Formulated Anti-malaria Vaccine Components), which is not on this map. Cited by 35 papers.
What it found
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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.
A Phase Ib Double-blind Randomized Placebo Controlled Age-deescalating Trial of Two Virosome Formulated Anti-malaria Vaccine Components (PEV 301 and PEV 302) Administered in Combination to Healthy Semi-immune Tanzanian Volunteers
Who cites it
35 citing papers in PubMed, 68 citations in OpenAlex.
- Antibody and T-cell responses associated with experimental human malaria infection or vaccination show limited relationships.Immunology · 2015Trial
- Virus Biomimetic-Delivery Systems for the Production of Vaccines.Biomimetics (Basel, Switzerland) · 2026Review
- Revolutionizing Nanovaccines: A New Era of Immunization.Vaccines · 2025Review
- Current progress in the development of prophylactic and therapeutic vaccines.Science China. Life sciences · 2023Review
- A low dose of RBD and TLR7/8 agonist displayed on influenza virosome particles protects rhesus macaque against SARS-CoV-2 challenge.Scientific reports · 2023Article
- Lipid-based regulators of immunity.Bioengineering & translational medicine · 2022Review
- Peptides for Vaccine Development.ACS applied bio materials · 2022Review
- A SARS-CoV-2 Wuhan spike virosome vaccine induces superior neutralization breadth compared to one using the Beta spike.Scientific reports · 2022Article
- Virosome-based nanovaccines; a promising bioinspiration and biomimetic approach for preventing viral diseases: A review.International journal of biological macromolecules · 2021Review
- Review
- Analysis of the Role of TpUB05 Antigen fromPathogens (Basel, Switzerland) · 2020Article
- Peptide-Based Vaccines: Current Progress and Future Challenges.Chemical reviews · 2020Review
- Vaccination with virosomally formulated recombinant CyRPA elicits protective antibodies againstNPJ vaccines · 2020Article
- Immunomodulatory Nanosystems.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2019Review
- Mucosal Vaccine Approaches for Prevention of HIV and SIV Transmission.Current immunology reviews · 2019Article
- Article
- Preclinical efficacy and immunogenicity assessment to show that a chimeric Plasmodium falciparum UB05-09 antigen could be a malaria vaccine candidate.Parasite immunology · 2018Article
- Article
- Pulmonary Delivery of Virosome-Bound Antigen Enhances Antigen-Specific CD4Frontiers in immunology · 2017Article
- Characterization of fine specificity of the immune response to a Plasmodium falciparum rhoptry neck protein, PfAARP.Malaria journal · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis trial was conducted to evaluate the safety and immunogenicity of two virosome formulated malaria peptidomimetics derived from Plasmodium falciparum AMA-1 and CSP in malaria semi-immune adults and children.
methodsThe design was a prospective randomized, double-blind, controlled, age-deescalating study with two immunizations. 10 adults and 40 children (aged 5-9 years) living in a malaria endemic area were immunized with PEV3B or virosomal influenza vaccine Inflexal®V on day 0 and 90.
resultsNo serious or severe adverse events (AEs) related to the vaccines were observed. The only local solicited AE reported was pain at injection site, which affected more children in the Inflexal®V group compared to the PEV3B group (p = 0.014). In the PEV3B group, IgG ELISA endpoint titers specific for the AMA-1 and CSP peptide antigens were significantly higher for most time points compared to the Inflexal®V control group. Across all time points after first immunization the average ratio of endpoint titers to baseline values in PEV3B subjects ranged from 4 to 15 in adults and from 4 to 66 in children. As an exploratory outcome, we found that the incidence rate of clinical malaria episodes in children vaccinees was half the rate of the control children between study days 30 and 365 (0.0035 episodes per day at risk for PEV3B vs. 0.0069 for Inflexal®V; RR = 0.50 [95%-CI: 0.29-0.88], p = 0.02).
conclusionThese findings provide a strong basis for the further development of multivalent virosomal malaria peptide vaccines.
trial registrationClinicalTrials.gov NCT00513669.
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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.