Immunity to Oral Polio Vaccine Clinical Trial
Official title:
Supplementation With Zinc and/or Probiotics to Enhance the Immune Response of Oral Rotavirus and Polio Vaccines in Indian Infants
| Verified date | December 2018 |
| Source | PATH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides
suboptimal protection in developing countries. Probiotics and zinc supplementation could
improve RV immunogenicity by altering the intestinal microbiota and immune function.
This study enrolled infants 5 weeks old living in urban Vellore, India to assess the effects
of daily zinc (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on the
immunogenicity of two doses of RV (Rotarix,GlaxoSmithKline Biologicals) given at 6 and 10
weeks of age. Probiotics and zinc (or placebo) were provided for six weeks. A single dose of
test product was administered daily one week prior to first study dose of rotavirus and polio
vaccines through 1 week following second study dose of rotavirus and polio vaccines.
| Status | Completed |
| Enrollment | 620 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 5 Weeks to 16 Weeks |
| Eligibility |
Inclusion Criteria: - Infants 35-41 days old - Live in area under surveillance - Current weight =3.2 kg - No syndromic evidence of immunocompromise as determined by medical doctor - No prior illness requiring hospitalization - No current medical condition as determined by medical doctor which precludes study involvement - Available for follow up for duration of study (through approximately 14 weeks of age) - Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent Exclusion Criteria: - Child has history of atopic symptoms - Child has a known digestive system defect - Child has history of chronic diarrhea - Child has major congenital anomalies - Child has received a prior dose of rotavirus vaccine - Child has received a prior dose of polio vaccine (beyond the birth dose) |
| Country | Name | City | State |
|---|---|---|---|
| India | Christian Medical Center, Vellore | Vellore | Tamil Nadu |
| Lead Sponsor | Collaborator |
|---|---|
| PATH | Christian Medical College, Vellore, India, Ministry of Science and Technology, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine | Defined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 immunoglobulin A (IgA) antibodies at a concentration =20 U/ml in a previously seronegative individual) or a fourfold rise in anti-RV VP6 IgA antibodies between baseline and 14 weeks of age. Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age). |
from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine | |
| Primary | Geometric Mean Concentration of Rotavirus-specific IgA | Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus was administered (14 weeks of age). Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age). |
from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine | |
| Secondary | Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV) | A serologic immune response to OPV is defined as a neutralizing antibody titer to polio virus subtype 3 greater than or equal to 1:8 at 14 weeks of age. This antigen will be used as a conservative estimate because it gives the lowest immune response of all three polio antigens. Pre-vaccination blood samples were taken when the subject received the first dose of OPV vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of OPV was administered (14 weeks of age). |
from first dose of OPV to 4 weeks after last dose of OPV | |
| Secondary | Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1 | Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by Real-time polymerase chain reaction (RT-PCR). Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination. | 0, 4 and/or 7 day post dose 1 of rotavirus vaccine | |
| Secondary | Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2 | Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by RT-PCR. Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination. | 0, 4 and/or 7 day post dose 2 of rotavirus vaccine | |
| Secondary | Serious Adverse Events (SAEs) | Field workers documented information on SAEs through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. All SAEs occurring at any time during the study were recorded on a SAE Form and were reviewed and evaluated by a study clinician and the local IRB. The relationship of the SAE to study vaccine was evaluated and recorded and reported to the local institutional review board (IRB). All SAEs were followed until satisfactory resolution. | from first day of study to 4 weeks after last dose |