Adults 6 Weeks to 15 Weeks, any sex, with Diarrhoea. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Immunized Infants Exposed to High Breast Milk Anti-rotavirus Immunoglobulin-A Who Fail to SeroconvertPrimary· 1 month following full immunization
The primary exposure in this cohort is maternal IgA status, as we believe breast milk IgA is the most critical factor in failed vaccination, and maternal IgA has previously been estimated to be either high level (approximately 55%) or undetectable or low level (approximately 45%).
We will collect maternal serum and breast-milk IgA at the time of vaccination and then measure infant anti-rotavirus-specific serum IgA levels 1 month following the second dose of Rotarix™ (GlaxoSmithKline) rotavirus vaccine.
Group
Value
95% CI
Mother-Infant Pair
0.602
Proportion of Immunized Infants Exposed to Maternal HIV Infection Who Fail to SeroconvertPrimary· 1 month after the two vaccine doses
To evaluate whether maternal HIV infection (as well as level of CD4 count) affects infant vaccine take, we will collect the maternal HIV status, (and CD4 count if +ve). We will then correlate the maternal HIC status and CD4 count levels to infant zero conversion at 1 month after the two vaccine doses.
Group
Value
95% CI
Mother/Infant Pair
0.704
Proportion of Immunized Infants With Low Micronutrient Levels (as Indicated by Serum Zinc and Vitamin A), Who Fail to SeroconvertSecondary· 1 month after full immunization
To evaluation whether nutritional status affects vaccine take, we will assess the immunized infant's nutritional status as indicated by serum level of zinc and vitamin A. These will be correlated to seroconversion results.
Group
Value
95% CI
Mother-Infant Pair
0.5
Sero-epidemiology of Breakthrough Rotavirus Infection in Immunized InfantsSecondary· 42 months
Determination of genotype in every rotavirus causing severe gastroenteritis will be done each time stool samples are collected for diarrhoea. Patients presenting with any diarrhoea will be tested for rotavirus and staged clinically (by Vesikari score). Those with severe disease (e.g., Vesikari \>11/20) will be processed for genotype. Thus, we will identify the number of rotavirus cases following vaccination as well as identify the strain in those with severe disease.
This will allow for "wild type versus vaccine"strain mismatch evaluation. We anticipate that the circulating strains in the com
Group
Value
95% CI
Infants
4
Infants
3
Infants
2
Infants
6
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Zambia recently introduced routine infant immunization against rotavirus - the most important cause of severe gastroenteritis and diarrhoea mortality in children. Although vaccines like Rotarix are a cost effective tool against infectious diseases, live oral vaccines can be less immunogenic and efficacious in developing world settings as compared with industrialized countries. Reasons behind this phenomenon are not well understood, but may relate to continued maternal antigen exposure and high level maternal immunity that is passed to the foetus/newborn transplacentally and/or through breast milk.
Therefore, three arising hypotheses include: (i) high-level rotavirus-specific maternal immunity (in the form of anti-rotavirus breast-milk immunoglobulin A (IgA) and transplacental serum IgG) is a major contributor to failed seroconversion following infant vaccination. (ii) Malnutrition negatively impacts infant immunity and increases the risk of post-vaccination rotavirus gastroenteritis. (iii) Introduction of rotavirus vaccine will alter the molecular epidemiology of circulating rotavirus strains detected in vaccinated children presenting with severe diarrhea.
To address these hypotheses, the proposed study will recruit a prospective cohort of 420 mother-infant pairs. These will be enrolled at the time of vaccination and followed for up to four years. Baseline immunological status will be ascertained and seroconversion rates determined a month after full immunization. Incident rotavirus gastroenteritis will be monitored in the vaccinated infants whenever episodes of diarrhoea occur; through this surveillance, the sero-strains of rotaviruses causing disease will be tracked over the four year period. Contributions of HIV infection both in mothers and infants, vitamin A and zinc deficiency, weight for age Z-scores as well as mid upper arm circumference will also be assessed. Knowledge gained from this study will inform future interventional trials on strategies to improve rotavirus vaccine effectiveness in the developing world.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06839586 — CMTS4520 for Chronic Diarrhoea in Adults
· Phase 1, PHASE2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre for Infectious Disease Research in Zambia
Last refreshed: 23 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01886833.