SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
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ClinicalTrials.gov Identifier: NCT03313128 |
Recruitment Status :
Recruiting
First Posted : October 18, 2017
Last Update Posted : March 30, 2023
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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.
Condition or disease | Intervention/treatment |
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Rotavirus Infections Environmental Enteric Dysfunction Enteric Infections | Other: Sanitation |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | SaniVac Trial: An Assessment of Oral Rotavirus Vaccine Performance Among Infants Enrolled in a Controlled Before-after Study in Low-income Neighbourhoods of Maputo, Mozambique |
Actual Study Start Date : | October 1, 2017 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Group/Cohort | Intervention/treatment |
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Historic intervention
Infants born into the historic intervention arm of sanitation trial (NCT02362932)
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Other: Sanitation
Improved sanitation facility |
Historic control
Infants born into the historic control arm of sanitation trial (NCT02362932)
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- Oral rotavirus vaccine seroconversion [ Time Frame: Approx. 16 weeks age of infant (4 weeks after second dose of oral rotavirus vaccine) ]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 infection [ Time Frame: Approx. 8 weeks age of infant (date of first dose of oral rotavirus 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 [ Time Frame: Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine) ]EED is measured via a combined disease activity score including faecal markers of intestinal inflammation and permeability: neopterin, α-1-antitrypsin, and myeloperoxidase in stool.
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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Pregnant women and their infants |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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 switch study compound over the next 9 months
- Mother being pregnant and having gestational age between 3 and 9 months or being puerperal (up to 40 days postpartum)
- Mother planning to use the prenatal care, delivery and vaccination services provided by the Ministry of Health of Mozambique
- Mother able to understand and complete the informed consent process and allow your newborn to participate in the study
- Mother at least 16 years of age
- Infant eligible to receive rotavirus vaccination
Exclusion criteria:
- Infant whose medical team considers that they cannot be part of the study
- Infant with complications associated with gestation, childbirth or postpartum, including congenital malformations
- Infant with any medical, psychiatric or social condition, occupational reason, or other responsibility on the part of the pregnant woman, which, in the opinion of the investigator, is a contraindication to protocol compliance or impedes the participant's ability to give informed consent
- Infant who has already received the rotavirus vaccine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313128
Contact: Oliver D Cumming, MSc | +442076368636 | oliver.cumming@lshtm.ac.uk |
Mozambique | |
Centro de Investigação em Saúde da Polana Caniço (CISPOC) | Recruiting |
Maputo, Mozambique, 264 | |
Contact: Edna Viegas, MD +258 21 43 08 14 ednaviegas@gmail.com |
Principal Investigator: | Oliver D Cumming, MSc | London School of Hygiene and Tropical Medicine | |
Principal Investigator: | Edna Viegas, MD | Centro de Investigação em Saúde da Polana Caniço (CISPOC) |
Responsible Party: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT03313128 |
Other Study ID Numbers: |
QA919 |
First Posted: | October 18, 2017 Key Record Dates |
Last Update Posted: | March 30, 2023 |
Last Verified: | March 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections Communicable Diseases Rotavirus Infections Disease Attributes |
Pathologic Processes Reoviridae Infections RNA Virus Infections Virus Diseases |