Evidence map›Paper›PMID 39340031›Full record

ArticleVaccines2024

Safety and Immunogenicity of the Intranasal Vaccine Candidate Mambisa and the Intramuscular Vaccine Abdala Used as Booster Doses for COVID-19 Convalescents: A Randomized Phase 1-2 Clinical Trial.

Gilda Lemos-Pérez, Yinet Barrese-Pérez, Yahima Chacón-Quintero, Rolando Uranga-Piña, Yisel Avila-Albuerne, Iglermis Figueroa-García, Osaida Calderín-Marín, Martha M Gómez-Vázquez, Marjoris Piñera-Martínez, Sheila Chávez-Valdés and 11 more

Abstract read
In one paragraph

Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Mucosal immunity and vaccine development.Signal transduction and targeted therapy · 2026
    Pooled it
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Gilda Lemos-PérezCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.ORCID 0000-0003-0596-6501
Yinet Barrese-PérezNational Coordinating Center for Clinical Trials (CENCEC), La Habana 11300, Cuba.
Yahima Chacón-QuinteroCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Rolando Uranga-PiñaNational Coordinating Center for Clinical Trials (CENCEC), La Habana 11300, Cuba.
Yisel Avila-AlbuerneNational Coordinating Center for Clinical Trials (CENCEC), La Habana 11300, Cuba.
Iglermis Figueroa-GarcíaHermanos Ameijeiras Clinical-Surgical Hospital, La Habana 10400, Cuba.
Osaida Calderín-MarínManuel Ascunce Domenech Provincial Clinical-Surgical Teaching Hospital, Camagüey 70100, Cuba.
Martha M Gómez-VázquezPedro Raúl Sánchez Teaching Polyclinic, Pinar del Río 20100, Cuba.
Marjoris Piñera-MartínezSaturnino Lora Provincial Clinical-Surgical Hospital, Santiago de Cuba 90100, Cuba.
Sheila Chávez-ValdésCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Ricardo Martínez-RosalesCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Lismary Ávila-DíazCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Amalia Vázquez-ArteagaCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Hany González-FormentalCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Giselle Freyre-CorralesCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Edelgis Coizeau-RodríguezCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Miladys Limonta-FernándezCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Marta Ayala-AvilaCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
Eduardo Martínez-DíazMinistry of Science, Technology and Environment (CITMA), La Habana 10400, Cuba.
Eulogio Pimentel-VazquezBiotechnology and Pharmaceutical Industries Group (BioCubaFarma), La Habana 10800, Cuba.
Gerardo GuillenCenter for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.ORCID 0000-0003-3098-0970

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A phase 1-2, prospective, multicenter, randomized, open-label clinical trial (Code RPCEC00000382), with parallel groups, involving 1161 participants, was designed to assess the safety and immunogenicity of two Cuban COVID-19 vaccines (Mambisa and Abdala) in boosting COVID-19 immunity of convalescent adults after receiving one dose of either vaccine. The main safety outcome was severe vaccination adverse events occurring in <5% of vaccinees. Main immunogenicity success endpoints were a ≥4-fold anti-RBD IgG seroconversion or a ≥20% increase in ACE2-RBD inhibitory antibodies in >55% of vaccinees in Phase 1 and >70% in Phase 2. Neutralizing antibody titers against SARS-CoV-2 variants were evaluated. Both vaccines were safe-no deaths or severe adverse events occurred. Mild intensity adverse events were the most frequent (>73%); headaches predominated for both vaccines. Phase 1 responders were 83.3% (

Indexed as

boosterconvalescentsCOVID-19 vaccinesCubaintramuscularintranasalSARS-CoV-2vaccination

Identifiers

PMID39340031
PMCPMC11435458

What OpenQuestion holds

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Registered trials

None linked

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.