Clinical trial NCT03313128: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotavirus Infections
Environmental Enteric Dysfunction
Enteric Infections
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Saúde, Mozambique
name: Georgia Institute of Technology
name: Centers for Disease Control and Prevention
First posted: 2017-10-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Oral rotavirus vaccine seroconversion
timeFrame: Approx. 16 weeks age of infant (4 weeks after second dose of oral rotavirus vaccine)
Secondary outcomes:
measure: Enteric infection
timeFrame: Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)
measure: Environmental Enteric Dysfunction
timeFrame: Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: Centro de Investigação em Saúde da Polana Caniço (CISPOC)
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Oliver D Cumming, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Investigação em Saúde da Polana Caniço (CISPOC)
name: Edna Viegas, MD
role: PRINCIPAL_INVESTIGATOR
References: