SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance

Last updated: March 29, 2023
Sponsor: London School of Hygiene and Tropical Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03313128
QA919
  • Ages > 16
  • Female
  • Accepts Healthy Volunteers

Study Summary

This is a controlled cohort study to assess the effect of improved sanitation on oral rotavirus vaccine performance in low-income urban neighbourhoods of Maputo, Mozambique. The specific hypotheses are that: (1) access to improved sanitation is associated with increased oral rotavirus vaccine immunogenicity; (2) enteric infection concurrent to oral rotavirus vaccination is associated with reduced oral rotavirus vaccine immunogenicity; and (3) Environmental Enteric Dysfunction is associated with reduced oral rotavirus vaccine immunogenicity.

Pregnant women will be enrolled from the intervention and control arms of a previous sanitation trial (NCT02362932) post-intervention and will be enrolled at no later than eight months' gestation and then followed to 4 months of age of the infant. Blood samples and faeces will be taken from the infant at the time of administration of the first dose of the oral rotavirus vaccine and four weeks after the second dose of the vaccine.

The primary outcome of interest in the study is oral rotavirus vaccine immunogenicity among participating vaccinated infants. Seroconversion is defined as a ≥ fourfold rise in serum anti-rotavirus IgA titers between first dose of oral RV vaccine and 4 weeks (+/- 1 week) after second dose of oral RV vaccine. Enteric infections are defined as the presence of ≥ 1 of the following enteric infections in stool: adenovirus 40/41, rotavirus A, norovirus GI/GII, Salmonella spp. (including serovars Typhi and Paratyphi), Campylobacter spp. (C. jejuni, C. coli, C. lari), Shigella spp. (S. boydii, S. sonnei, S. flexneri, S. dysenteriae), Clostridium difficile Toxin A/B, enterotoxigenic Escherichia coli (ETEC) LT/ST, E. coli O157, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, Yersinia enterocolitica, Vibrio cholerae, Giardia lamblia, Entamoeba histolytica, and Cryptosporidium spp. (C. parvum, C. hominis). Environmental Enteric Dysfunction is measured via a combined disease activity score including faecal markers of intestinal inflammation and permeability: neopterin, α-1 antitrypsin, and myeloperoxidase in stool.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Mother residing in an intervention or control compound of a previous sanitation trial (NCT02362932) for at least 6 months prior to recruitment and not intending to switchstudy compound over the next 9 months
  2. Mother being pregnant and having gestational age between 3 and 9 months or beingpuerperal (up to 40 days postpartum)
  3. Mother planning to use the prenatal care, delivery and vaccination services providedby the Ministry of Health of Mozambique
  4. Mother able to understand and complete the informed consent process and allow yournewborn to participate in the study
  5. Mother at least 16 years of age
  6. Infant eligible to receive rotavirus vaccination

Exclusion

Exclusion criteria:

  1. Infant whose medical team considers that they cannot be part of the study
  2. Infant with complications associated with gestation, childbirth or postpartum,including congenital malformations
  3. Infant with any medical, psychiatric or social condition, occupational reason, orother responsibility on the part of the pregnant woman, which, in the opinion of theinvestigator, is a contraindication to protocol compliance or impedes theparticipant's ability to give informed consent
  4. Infant who has already received the rotavirus vaccine

Study Design

Total Participants: 200
Study Start date:
October 01, 2017
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Centro de Investigação em Saúde da Polana Caniço (CISPOC)

    Maputo, 264
    Mozambique

    Active - Recruiting

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