Improving Rotavirus Vaccine Immune Response
4 april 2013 uppdaterad av: International Centre for Diarrhoeal Disease Research, Bangladesh
Improving the Immune Response to Rotavirus Vaccine
Rotavirus is the leading cause of severe gastroenteritis in infants and young children worldwide and is estimated to account for 600,000 deaths in children <5 years of age.
However, live oral enteric vaccines (e.g.
OPV, cholera vaccines, typhoid vaccine) have been less immunogenic in poor communities with high levels of malnutrition and poor sanitation.
Rotavirus vaccines also appear to be less immunogenic in the setting where they are most needed.
High maternal antibody (IgG) to rotavirus and breast feeding near the time of vaccination may inhibit rotavirus vaccine effectiveness.
We propose a quick study to look at practical ways to improve the immunogenicity of rotavirus vaccine in our own setting in Bangladesh.
The objectives are to assess if delaying Rotarix vaccination will improve the immune response to the vaccine and to assess if avoiding breastfeeding in the 45 minutes before and after vaccine administration will improve the immune response to administration of Rotarix vaccine.
The study will be conducted in the urban Dhaka Mirpur Community, a setting where previous rotavirus vaccine immunogenicity studies have been successfully conducted.
A total of 300 infant will be randomly assigned to one of the following groups: 1) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
2) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
3) Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
4) Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Blood and stool samples will be collected from infants and breast milk from mothers.
The primary outcome is to determine the sero-conversion rate of anti-rotavirus IgA in different groups of infants.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
The study will be conducted in a suburb of Dhaka in the area of Mirpur. Mirpur is one of the 14 Thanas of Dhaka cities with a population of about one million in an area of 59 square kilometers. Mirpur Thana of Dhaka city is divided into several sections. There are 14 sections in Mirpur Thana. The area is densely populated and located 20 minutes away from the lCDDR,B's Dhaka Hospital . The population is stable with low socioeconomic conditions. The average income in the slum areas of Mirpur is Tk.4200 (about US $ 62) per month per family. 25% of fathers and 15% of mothers have more than 5 years of formal education. The study will be conducted in section 11 and 12 of Mirpur which has a population of about 500,000. We recently conducted phase I and II of the rotavirus vaccine study in this site. Several other studies (phase II ETEC, killed cholera vaccine) are ongoing in this area. Children will be identified through active surveillance of new births in the community and the study subjects will be recruited through home visits by the locally recruited field workers.
2.2 .Design : Randomized intervention trial
Study groups:
- Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
- Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
- Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
- Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Samples collected:
- Blood draw at the time of first dose of Rotavirus vaccine and 4 weeks after the second dose
- Breast milk sample at 6 weeks for the mothers in study groups A and B, and at 14 weeks for mothers in study groups C and D (see below for groups).
- Stool sample prior to dose one and on day 3 and 7 after each dose to look for vaccine virus shedding
Studietyp
Interventionell
Inskrivning (Faktisk)
300
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Dhaka, Bangladesh, 1216
- Mirpur
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 månad till 45 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- male or female,
- aged 6 weeks at the time of enrollment,
- written informed consent,
- free of chronic or serious medical condition as determined by history and physical exam and plan to stay in community for at least 6 months
Exclusion Criteria:
- fever (>38 C),
- acute or chronic illness,
- use of antimicrobial drug within previous 14 days,
- hypersensitivity to any of the vaccine components (see vaccine composition),
- use of any investigational drug during previous 30 days,
- any uncorrected congenital malformation of the gastrointestinal tract,
- use of any immunosuppressing drugs during the last 14 days (likelihood is remote),
- any evidence by physical exam of immunosuppresing condition,
- administration of gamma globulin or any other blood product,
- previous intussusception or abdominal surgery.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 6 weeks RV & normal breast feeding
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
|
Experimentell: 6 weeks RV & delayed breastfeeding
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
|
Experimentell: 14 weeks RV & Normal breastfeeding
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
|
Experimentell: 14 weeks RV & delayed breastfeedin
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Immunogenicity of Rotavirus Vaccine
Tidsram: 24 months
|
Sero-conversion rate of anti-rotavirus IgA
|
24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
anti-rotavirus IgA
Tidsram: 24 months
|
Geometric mean concentration of anti-rotavirus IgA Enterovirus excretion in children at the time of vaccination
|
24 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2010
Primärt slutförande (Faktisk)
1 april 2011
Avslutad studie (Faktisk)
1 december 2011
Studieregistreringsdatum
Först inskickad
2 april 2013
Först inskickad som uppfyllde QC-kriterierna
4 april 2013
Första postat (Uppskatta)
5 april 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 april 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 april 2013
Senast verifierad
1 december 2009
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PR-09070
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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