Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280111
Status:
COMPLETED
Last Update Posted:
2008-07-02
First Post:
2006-01-13
Brief Title:
Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants
Sponsor:
Society for Applied Studies
Organization:
Society for Applied Studies
Study Overview
Official Title:
Reactogenicity and Immunogenicity of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Healthy Non-Malnourished Infants 8-12 Weeks of Age
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It has been observed that in children who get a severe rotavirus infection subsequent infections cause either no symptoms or generally only mild or moderate diarrhea This evidence is the basis for developing a vaccine since it suggests that the first infection immunizes the child against disease upon re-infection
It was found that neonatal avirulent strains 116E and I321 induce protective immunity and offer clinical protection for at least one year Both these strains are well characterized and the safety studies have been done in animal models These candidate vaccine strains have been evaluated for safety and immunogenicity in adults and children 2 to 12 years of age by a randomized double blind placebo controlled trial in Cincinnati USA In India the diversity of rotavirus strains is greater and there is greater prevalence of malnutrition and co-infection with other enteric pathogens These vaccines have therefore also been tested in India
It was found that neonatal avirulent strains 116E and I321 induce protective immunity and offer clinical protection for at least one year Both these strains are well characterized and the safety studies have been done in animal models These candidate vaccine strains have been evaluated for safety and immunogenicity in adults and children 2 to 12 years of age by a randomized double blind placebo controlled trial in Cincinnati USA In India the diversity of rotavirus strains is greater and there is greater prevalence of malnutrition and co-infection with other enteric pathogens These vaccines have therefore also been tested in India
Detailed Description:
This study was a phase I randomized double blind safety and immunogenicity study of live attenuated neonatal rotavirus vaccine candidate strains 116E or I321 in healthy non-malnourished infants aged 8-12 weeks Informed written witnessed consent was obtained from the parents before infants were screened at 6 weeks of age Infants n90 were randomized 30 per group to receive one dose of either the 116E or I321 vaccines 105 fluorescence focus units FFu or placebo at 8 weeks of age The rotavirus vaccine was administered at a different time than DPT Diptheria-Pertussis-Tetanus OPV Oral Polio Vaccine and HBV Hepatitis B vaccine immunization since the trial represented the first safety study in infants with these strains The DPT OPV and HBV vaccines were given at the regular EPI schedule of 6 10 and 14 weeks with the precautions and techniques routinely in place for these
The test article was administered orally two weeks after the first DPT OPV and HBV dose after half an hour of administering 25 ml bicarbonate to buffer stomach acidity
Evaluation of reactogenicity consisted of daily recording of symptoms reported by the mothercaregiver and twice-daily axillary temperature measurements for 14 days post administration of vaccineplacebo Stool specimens were collected before administration of vaccineplacebo twice during the week following administration days 3 and 7 and at day 28 after administration to evaluate for vaccine virus shedding Weekly recording of adverse events was also done for the next 2 weeks ie on days 21 and 28 post administration of vaccineplacebo If gastrointestinal signs or symptoms occurred any time during the 4 weeks observation period attempts were made to collect stool samples daily maximum 2 per day while the illness persisted to be examined for the presence of the vaccine strains
Immunogenicity was determined by analysis of sera obtained before immunization and 28 days after immunization for changes in titers of rotavirus antibodies
The test article was administered orally two weeks after the first DPT OPV and HBV dose after half an hour of administering 25 ml bicarbonate to buffer stomach acidity
Evaluation of reactogenicity consisted of daily recording of symptoms reported by the mothercaregiver and twice-daily axillary temperature measurements for 14 days post administration of vaccineplacebo Stool specimens were collected before administration of vaccineplacebo twice during the week following administration days 3 and 7 and at day 28 after administration to evaluate for vaccine virus shedding Weekly recording of adverse events was also done for the next 2 weeks ie on days 21 and 28 post administration of vaccineplacebo If gastrointestinal signs or symptoms occurred any time during the 4 weeks observation period attempts were made to collect stool samples daily maximum 2 per day while the illness persisted to be examined for the presence of the vaccine strains
Immunogenicity was determined by analysis of sera obtained before immunization and 28 days after immunization for changes in titers of rotavirus antibodies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AI053719-02 | NIH | None | httpsreporternihgovquickSearchU01AI053719-02 |