N/A
N=174
Vaccine Hyporesponse in Healthy Elderly Participants (MK-0000-131 AM2)
Vaccine Response Impaired
Bottom Line
View on ClinicalTrials.gov: NCT01119703 ↗Enrolled (actual)
174
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. — 2.27; 2.12 ln International Units
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tetanus & Diphtheria booster vaccine (Td) (Biological); TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] (Biological); Dukoral® Traveler's Diarrhea Vaccine (WC/rBS) (Biological)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. |
2.27; 2.12 | — |
| PRIMARY Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. |
1.40; 1.32 | — |
| PRIMARY Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. |
-0.43; -0.46 | — |
| PRIMARY Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. |
5.24; 5.20 | — |
| PRIMARY Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants. |
2.12; 1.32; -0.46; 5.20 | 0.66 |
| SECONDARY Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. |
2.25; 2.12 | — |
| SECONDARY Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. |
1.43; 1.32 | — |
| SECONDARY Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. |
-0.37; -0.46 | — |
| SECONDARY Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. |
5.24; 5.20 | — |
Summary
This study evaluated whether it is possible in healthy elderly participants to generate baseline biomarker-based prediction rules (PdR) for vaccine response (post baseline absolute serum antibody titer) using each of the protocol selected vaccines separately; and examined the rank correlation coefficients of pairs of post vaccination antibody titers within the same elderly individuals.
Eligibility Criteria
Inclusion Criteria
- Male or female aged 25 to 40 years old or 65 years of age or older at the prestudy (screening) visit
- Has no fever on day of screening
- Lacks Hepatitis B surface antigen seroreactivity
- If female 25 to 40 years of age, is not pregnant nor breastfeeding, and agrees to use effective contraception
Exclusion Criteria
- Has a prior history of Hepatitis B Virus infection
- Has BMI (Body Mass Index) >35
- If female 25 to 40 years of age, is pregnant, or expecting to conceive, donate eggs or breastfeed
- Has received immune globulin and/or blood products within 3 months prior to first dose received
- Has a history of immunosuppression resulting from disease (e.g., malignancy; human immunodeficiency virus [HIV] infection), or is currently taking corticosteroids or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation)
- Has an active neoplastic disease
- Has had any infection including upper respiratory viral syndrome in the 6 weeks prior to planned collection of baseline laboratory samples
- Has received a live virus vaccine or an inactivated vaccine or is scheduled to receive a live virus vaccine or an inactivated vaccine in the period from 6 weeks prior to receipt of the first vaccine through the completion of all study visits
Data sourced from ClinicalTrials.gov (NCT01119703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.