Trial reportThe Journal of infectious diseases2012
Clinical evaluation of safety and immunogenicity of PADRE-cytomegalovirus (CMV) and tetanus-CMV fusion peptide vaccines with or without PF03512676 adjuvant.
Trial report in The Journal of infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00722839 (A Phase I Dose Escalation Study of Peptide Vaccines With Activity Against Human Cytomegalovirus), which is not on this map. Cited by 51 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 I Dose Escalation Study of Peptide Vaccines With Activity Against Human Cytomegalovirus
Who cites it
51 citing papers in PubMed.
- Poxvirus Vectored Cytomegalovirus Vaccine to Prevent Cytomegalovirus Viremia in Transplant Recipients: A Phase 2, Randomized Clinical Trial.Annals of internal medicine · 2020Trial
- Viraemia, immunogenicity, and survival outcomes of cytomegalovirus chimeric epitope vaccine supplemented with PF03512676 (CMVPepVax) in allogeneic haemopoietic stem-cell transplantation: randomised phase 1b trial.The Lancet. Haematology · 2016Trial
- Trial
- Article
- Protective immunity against malaria by a nanoparticle CIS43-based junctional vaccine alone or in combination with R21.NPJ vaccines · 2026Article
- DNA origami vaccines program antigen-focused germinal centers.Science (New York, N.Y.) · 2026Article
- Article
- Protective immunity against malaria by a nanoparticle CIS43-based junctional vaccine alone or in combination with R21.bioRxiv : the preprint server for biology · 2025Article
- Designing a Multi-Epitope Vaccine Against MPXV and HIV Based on an Immunoinformatic Approach.International journal of molecular sciences · 2025Article
- Article
- Polymeric Nanoparticles as Oral and Intranasal Peptide Vaccine Delivery Systems: The Role of Shape and Conjugation.Vaccines · 2024Article
- Article
- Lessons from Acquired Natural Immunity and Clinical Trials to Inform Next-Generation Human Cytomegalovirus Vaccine Development.Annual review of virology · 2022Review
- Article
- Peptide-Based Vaccine against SARS-CoV-2: Peptide Antigen Discovery and Screening of Adjuvant Systems.Pharmaceutics · 2022Article
- Development of CMV-CD19 bi-specific CAR T cells with post-infusion in vivo boost using an anti-CMV vaccine.International journal of hematology · 2021Review
- Evaluation of the AV7909 Anthrax Vaccine Toxicity in Sprague Dawley Rats Following Three Intramuscular Administrations.International journal of toxicology · 2021Article
- In-depth summary over cytomegalovirus infection in allogeneic hematopoietic stem cell transplantation recipients.Virusdisease · 2021Review
- Development of a Vaccine against Human Cytomegalovirus: Advances, Barriers, and Implications for the Clinical Practice.Vaccines · 2021Review
- Review
Corrections and comments
- Erratum issuedDadwal, Sanjeet [added]
Authors and funding
18 authors.
Funding
Abstract
backgroundIt has been reported that cytomegalovirus (CMV) pp65-specific T cells can protect hematopoietic cell transplant (HCT) recipients from CMV complications. Two candidate CMV peptide vaccines composed of the HLA A*0201 pp65(495-503) cytotoxic CD8(+) T-cell epitope fused to 2 different universal T-helper epitopes (either the synthetic Pan DR epitope [PADRE] or a natural Tetanus sequence) were clinically evaluated for safety and ability to elicit pp65 T cells in HLA A*0201 healthy volunteers.
methodsEscalating doses (0.5, 2.5, 10 mg) of PADRE or Tetanus pp65(495-503) vaccines with (30 adults) or without (28 adults) PF03512676 adjuvant were administered by subcutaneous injection every 3 weeks for a total of 4 injections.
resultsNo serious adverse events were reported, although vaccines used in combination with PF03512676 had enhanced reactogenicity. Ex vivo responses were detected by flow cytometry exclusively in volunteers who received the vaccine coadministered with PF03512676. In addition, using a sensitive in vitro stimulation system, vaccine-elicited pp65(495-503) T cells were expanded in 30% of volunteers injected solely with the CMV peptides and in all tested subjects receiving the vaccines coinjected with PF03512676.
conclusionsAcceptable safety profiles and vaccine-driven expansion of pp65(495-503) T cells in healthy adults support further evaluation of CMV peptide vaccines combined with PF03512676 in the HCT setting. CLINICAL TRIALS REGISTRATION: NCT00722839.
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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.