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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 : October 24, 2017
Sponsor:
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

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.


Condition or disease Intervention/treatment
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, 2018
Estimated Study Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
Historic intervention
Infants born into the historic intervention arm of sanitation trial (NCT02362932)
Other: Sanitation
Improved sanitation facility

Historic control
Infants born into the historic control arm of sanitation trial (NCT02362932)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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
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.
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

Information from the National Library of Medicine

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


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

Locations
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   
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
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 (LSHTM)
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     History of Changes
Other Study ID Numbers: QA919
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases