SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance

Rotavirus Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03313128
• Other study ID #: QA919
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: London School of Hygiene and Tropical Medicine
• Contact: Oliver D Cumming, MSc
• Phone: +442076368636
• Email: oliver.cumming[@]lshtm.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Enteric Infections
• Environmental Enteric Dysfunction
• Infections
• Rotavirus Infections

Intervention

Other:
• Sanitation
Improved sanitation facility

Locations

Country	Name	City	State
Mozambique	Centro de Investigação em Saúde da Polana Caniço (CISPOC)	Maputo

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Centers for Disease Control and Prevention, Georgia Institute of Technology, Instituto Nacional de Saúde, Mozambique

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral rotavirus vaccine seroconversion	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	Approx. 16 weeks age of infant (4 weeks after second dose of oral rotavirus vaccine)
Secondary	Enteric infection	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).	Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)
Secondary	Environmental Enteric Dysfunction	EED is measured via a combined disease activity score including faecal markers of intestinal inflammation and permeability: neopterin, a-1-antitrypsin, and myeloperoxidase in stool.	Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)