Clinical trial NCT01119703: Vaccine Hyporesponse in Healthy Elderly Participants (MK-0000-131 AM2)
Official title: A Phase I, Open-Label Observational Study to Develop a Prospective Predictor of Vaccine Hyporesponse in Healthy Elderly Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Response Impaired
Keywords: Vaccine Hyporesponse
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 174
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults 25 to 40 years old or 65 years and older

Brief 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

Primary outcomes:
measure: Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
timeFrame: Baseline and 1 month after final vaccination
measure: Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
timeFrame: Baseline and 1 month after final vaccination
measure: Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
timeFrame: Baseline and 1 month after final vaccination
measure: Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
timeFrame: Baseline and 3 weeks after final vaccination
measure: Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants.
timeFrame: 3 weeks or 1 month after each final vaccination
Secondary outcomes:
measure: 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.
timeFrame: Day 7 and 1 month after final vaccination
measure: Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
timeFrame: Day 7 and 1 month after each final vaccination
measure: Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
timeFrame: Day 7 and 1 month after final vaccination
measure: Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
timeFrame: Day 7 and 3 weeks after final vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Anapharm
name: Francois St-Maurice, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anapharm
name: Denis Audet, MD
role: PRINCIPAL_INVESTIGATOR
References: