Rotavirus InfectionsNCT03313128
SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
An observational study of Rotavirus Infections and Environmental Enteric Dysfunction, run by London School of Hygiene and Tropical Medicine at 1 site in Mozambique.
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)… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infections, Environmental Enteric Dysfunction, Enteric Infections
- What is being tested?
- Sanitation
- How many people
- 261 participants
- Where
- 1 siteMozambique
- Study dates
- 5 Oct 2017to 12 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mozambique1 site
Centro de Investigação em Saúde da Polana Caniço (CISPOC)
Maputo, 264
About this study
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
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.
- Being tested
- Sanitation
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SanitationOther
Improved sanitation facility
| Study group | Role | What they receive |
|---|---|---|
| Historic intervention | Infants born into the historic intervention arm of sanitation trial (NCT02362932) Receives: Other: Sanitation | |
| Historic control | Infants born into the historic control arm of sanitation trial (NCT02362932) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approx. 16 weeks age of infant (4 weeks after second dose of oral rotavirus vaccine)
Secondary outcomes (2)
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).
Measured: Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)
Environmental Enteric Dysfunction
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.
Measured: Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start5 Oct 2017
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Saúde, Mozambique, Georgia Institute of Technology, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Oliver D Cumming, MSc, Principal investigator, London School of Hygiene and Tropical MedicineEdna Viegas, MD, Principal investigator, Centro de Investigação em Saúde da Polana Caniço (CISPOC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313128
- Sponsor's protocol ID
- QA919
- Status last verified
- Dec 2025
- First submitted
- 6 Oct 2017
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03313128
- Acronym / sponsor ID
- QA919
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Instituto Nacional de Saúde, Mozambique, Georgia Institute of Technology, Centers for Disease Control and Prevention
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historic intervention | – | Other: SanitationInfants born into the historic intervention arm of sanitation trial (NCT02362932) |
| Historic control | – | –Infants born into the historic control arm of sanitation trial (NCT02362932) |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SanitationImproved sanitation facility | Other | Historic intervention |
Primary outcome
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
2 secondary outcomes
Enteric infection
Time frame: Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)
Environmental Enteric Dysfunction
Time frame: Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver D Cumming, MSc principal investigator
London School of Hygiene and Tropical Medicine
Edna Viegas, MD principal investigator
Centro de Investigação em Saúde da Polana Caniço (CISPOC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Infections and Environmental Enteric Dysfunction, run by London School of Hygiene and Tropical Medicine at 1 site in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral rotavirus vaccine seroconversion (time frame: Approx. 16 weeks age of infant (4 weeks after second dose of oral rotavirus vaccine)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.