SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance

• ClinicalTrials.gov Identifier: NCT03313128
• Recruitment Status: Recruiting
• First Posted: October 18, 2017
• Last Update Posted: March 30, 2023
• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Instituto Nacional de Saúde, Mozambique; Georgia Institute of Technology; Centers for Disease Control and Prevention
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine

Tracking Information

• First Submitted Date: October 6, 2017
• First Posted Date: October 18, 2017
• Last Update Posted Date: March 30, 2023
• Actual Study Start Date: October 1, 2017
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 17, 2017)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 17, 2017)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
• 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

Brief 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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Pregnant women of gestational age between 3-9 months (and postpartum) residing in the historic intervention and control compounds of a previous sanitation trial (NCT02362932) and their descendant(s) [infant(s)] of that pregnancy.

Condition

• Rotavirus Infections
• Environmental Enteric Dysfunction
• Enteric Infections

Intervention

Other: Sanitation

Improved sanitation facility

Study Groups/Cohorts

• Historic intervention
  Infants born into the historic intervention arm of sanitation trial (NCT02362932)
  Intervention: Other: Sanitation
• Historic control
  Infants born into the historic control arm of sanitation trial (NCT02362932)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 17, 2017): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 switch study compound over the next 9 months
2. Mother being pregnant and having gestational age between 3 and 9 months or being puerperal (up to 40 days postpartum)
3. Mother planning to use the prenatal care, delivery and vaccination services provided by the Ministry of Health of Mozambique
4. Mother able to understand and complete the informed consent process and allow your newborn to participate in the study
5. Mother at least 16 years of age
6. Infant eligible to receive rotavirus vaccination

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, 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
4. Infant who has already received the rotavirus vaccine

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant women and their infants

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Oliver D Cumming, MSc; +442076368636; oliver.cumming@lshtm.ac.uk

• Listed Location Countries: Mozambique

Administrative Information

• NCT Number: NCT03313128
• Other Study ID Numbers: QA919
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: London School of Hygiene and Tropical Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: London School of Hygiene and Tropical Medicine
• Original Study Sponsor: Same as current

Collaborators

• Instituto Nacional de Saúde, Mozambique
• Georgia Institute of Technology
• Centers for Disease Control and Prevention

Investigators

• 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)

• PRS Account: London School of Hygiene and Tropical Medicine
• Verification Date: March 2023