Evidence map›Paper›PMID 34838689›Full record

ArticleReproductive toxicology (Elmsford, N.Y.)2022

Lack of effects on female fertility or pre- and postnatal development of offspring in rats after exposure to AS03-adjuvanted recombinant plant-derived virus-like particle vaccine candidate for COVID-19.

Charlotte Dubé, Sarah Paris-Robidas, Iryna Primakova, Eric Destexhe, Brian J Ward, Nathalie Landry, Sonia Trépanier

Open access · greenAbstract read
In one paragraph

Article in Reproductive toxicology (Elmsford, N.Y.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 25% of its field
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, 9 citations in OpenAlex.

  1. Review
  2. Article
  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

7 authors at 4 institutions in 2 countries.

Charlotte DubéMedicago Inc., 1020 route de l'Église office 600, Québec, QC, G1V 3V9, Canada.
Sarah Paris-RobidasMedicago Inc., 1020 route de l'Église office 600, Québec, QC, G1V 3V9, Canada.
Iryna PrimakovaCharles River Laboratories Montreal ULC, 22022 Transcanadienne, Senneville, QC, H9X 3R3, Canada.
Eric DestexheGlaxoSmithKline Biologicals, Rue de l'Institut 89, 1330, Rixensart, Belgium.
Brian J WardMedicago Inc., 1020 route de l'Église office 600, Québec, QC, G1V 3V9, Canada; Research Institute of the McGill University Health Centre, 1001 Decarie St, Montreal, QC, H4A 3J1, Canada.
Nathalie LandryMedicago Inc., 1020 route de l'Église office 600, Québec, QC, G1V 3V9, Canada.
Sonia TrépanierMedicago Inc., 1020 route de l'Église office 600, Québec, QC, G1V 3V9, Canada. Electronic address: Trepaniers@medicago.com.
Medicago (Canada) · CAGlaxoSmithKline (Belgium) · BEMcGill University Health Centre · CATransCanada (Canada) · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection resulting in the coronavirus disease 2019 (COVID-19) has afflicted tens of millions of people in a worldwide pandemic. A recently developed recombinant Plant-Derived Virus-Like Particle Vaccine candidate for COVID-19 (CoVLP) formulated with AS03 has been shown to be well-tolerated and highly immunogenic in healthy adults. Since the target population for the vaccine includes women of childbearing potential, the objective of the study was to evaluate any untoward prenatal and postnatal effects of AS03-adjuvanted CoVLP administered intramuscularly to Sprague-Dawley female rats before cohabitation for mating (22 and 8 days prior) and during gestation (Gestation Days [GD] 6 and 19). The embryo-fetal development (EFD) cohort was subjected to cesarean on GD 21 and the pre/post-natal (PPN) cohort was allowed to naturally deliver. Effects of AS03-adjuvanted CoVLP was evaluated on pregnant rats, embryo-fetal development (EFD), during parturition, lactation and the development of the F1 offspring up to weaning Vaccination with AS03-adjuvanted CoVLP induced an antibody response in F0 females and anti-SARS-CoV-2 spike-specific maternal antibodies were detected in the offspring at the end of the gestation and lactation periods. Overall, there was no evidence of untoward effects of AS03-adjuvanted CoVLP on the fertility or reproductive performance of the vaccinated F0 females. There was no evidence of untoward effects on embryo-fetal development (including teratogenicity), or early (pre-weaning) development of the F1 offspring. These results support the acceptable safety profile of the AS03-adjuvanted CoVLP vaccine for administration to women of childbearing potential.

Indexed as

COVID-19 Vaccinesalpha-TocopherolAnimalsAnimals, NewbornAntibodies, ViralCOVID-19Drug CombinationsEmbryonic DevelopmentFemaleFertilityFetal DevelopmentImmunoglobulin GMaternal-Fetal ExchangeNicotianaPolysorbatesPregnancyalpha-TocopherolAntibodies, ViralAS03 adjuvantCOVID-19 VaccinesDrug CombinationsImmunoglobulin GPolysorbatesRecombinant ProteinsSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2SqualeneVaccines, Virus-Like ParticleAS03COVID-19 vaccineDevelopmental and reproductive toxicity studyFertilityImmunogenicityPregnancySARS-CoV-2Virus-like particles

Identifiers

PMID34838689
PMCPMC8611889
OpenAlexW3216176523

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.