Back to results

Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort (SLVP033)

Primary Purpose

Influenza, Hepatitis A, Typhoid

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fluzone® quadrivalent

Fluzone High Dose

Fluad

Vaqta

Typhim Vi

Vivotif

About this trial

This is an interventional basic science trial for Influenza focused on measuring Inactivated, quadrivalent influenza vaccine, Inactivated Hepatitis A vaccine, Inactivated, trivalent high-dose influenza vaccine, Typhoid Vi Polysaccharide Vaccine, Typhoid Vaccine Live Oral Ty21a, Influenza Vaccine, Adjuvanted

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study.
Prior participant in either the Ellison cohort or another Stanford vaccine study with archived samples.
Male or female, aged 18-40 years or 65 years and older.
In good general health as evidenced by medical history.

Exclusion Criteria:

Prior off-study vaccination with the current season influenza vaccine for influenza vaccinations.
Allergy to egg or egg products
Allergy to vaccine components, including thimerosal
Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
Receipt of blood or blood products within the past 6 months of any study vaccination or planned receipt of blood products prior to completion of Day 28 post-immunization visit.
Receipt of inactivated vaccine 14 days prior to study vaccination or planned vaccination prior to Day 28 after study vaccination.
Receipt of live, attenuated vaccine within 60 days of study vaccination or planned vaccination prior to Day 28 after study vaccination.
Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned blood donation prior to Day 28 after study vaccination.
Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of all study visits.
Need for allergy immunizations (that cannot be postponed) between Days 0 and 28 post-immunization.
Pregnant or lactating woman for all but influenza vaccine. A woman who is pregnant or breastfeeding may be evaluated by the Protocol Director to determine if influenza vaccination would affect volunteer safety and may be included at the discretion of the investigator. Blood sample collection will be adjusted as necessary for volunteer safety (e.g. blood collection volume for a pregnant woman would follow the minimal risk guidelines of 50 ml in an 8 week period and collection may not occur more frequently than 2 times per week).
Any condition, which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

Sites / Locations

Stanford LPCH Vaccine Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Group A IIV4

Group B High Dose IIV3

Group B Fluad

Group A Hepatitis A (HepA)

Group B Hepatitis A

Group A Typhoid VI

Group A Oral Typhoid

Group B Typhoid VI

Arm Description

Group A: Up to 30 healthy volunteers 18-40 years old, will be given seasonal quadrivalent inactivated influenza vaccine (IIV4) Fluzone® Quadrivalent vaccine. Each volunteer will complete a total of 4 visits: Day 0 (pre-immunization), Day 6-8, Day 12-16, and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Group B: Up to 15 healthy volunteers 65 plus years old, will be given seasonal high dose trivalent inactivated influenza vaccine (Fluzone High Dose) Fluzone® high dose vaccine. Each volunteer will complete a total of 4 visits: Day 0 (pre-immunization), Day 6-8, Day 12-16, and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Group B: Up to 15 healthy volunteers 65 plus years old, will be given seasonal adjuvanted trivalent inactivated influenza vaccine Fluad®. Each volunteer will complete a total of 4 visits: Day 0 (pre-immunization), Day 6-8, Day 12-16, and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Group A: Up to 30 healthy volunteers 18-40 years old, will be given inactivated Hepatitis A vaccine Vaqta® in year 1 of the study and a booster 12 months post primary Vaqta vaccination. Each volunteer will complete a total of 4 visits per vaccination: Day 0 (pre-immunization), Day 6-8, Day 12-16, and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Group B: Up to 30 healthy volunteers 65 plus years old, will be given inactivated Hepatitis A vaccine Vaqta® in year 1 of the study and a booster 12 months post primary Vaqta vaccination. Each volunteer will complete a total of 4 visits per vaccination: Day 0 (pre-immunization), Day 6-8, Day 12-16, and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Group A: Up to 15 healthy volunteers 18-40 years old, will be randomized to either Typhoid Vi Polysaccharide Vaccine (Typhoid VI), Typhim Vi®, or Typhoid Vaccine Live Oral Ty21a, Vivotif®. This arm represents those randomized to Typhoid VI. Each volunteer will complete a total of 4 visits: Day 0 (pre-immunization), Day 6-8, Day 12-16, and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Group A: Up to 15 healthy volunteers 18-40 years old, will be randomized to either Typhoid Vi Polysaccharide Vaccine, Typhim Vi®, or Typhoid Vaccine Live Oral Ty21a, Vivotif® (Oral Typhoid). This arm represents those randomized to Oral Typhoid. Each volunteer will complete a total of 4 visits: Day 0 (pre-immunization), Day 6-8 (from date of last oral dose), Day 12-16, and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Group B: Up to 30 healthy volunteers 65 plud years old, will be given Typhoid Vi Polysaccharide Vaccine (Typhoid VI), Typhim Vi® vaccine. Each volunteer will complete a total of 4 visits: Day 0 (pre-immunization), Day 6-8, Day 12-16, and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Outcomes

Primary Outcome Measures

hemagglutination inhibition assay (HAI) titers

HAI titers measured at Days 0 and 28 for influenza.

Secondary Outcome Measures

related AEs occurring during the 28 days post vaccination

related AEs occurring during the 28 days post vaccination for each of the vaccination types (Influenza, Hepatitis A, Typhoid)

Full Information

NCT ID

NCT03312699

First Posted

October 12, 2017

Last Updated

April 17, 2023

Sponsor

Stanford University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT03312699

Brief Title

Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort

Acronym

SLVP033

Official Title

Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 19, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to use an existing, unique clinical cohort: the longitudinal cohort of younger (21-40 years) and elderly (>65 years) subjects whose yearly influenza vaccine responses have been studied extensively since 2007, to gain molecular and cellular mechanistic insights into the impaired vaccine responses in the elderly.

Detailed Description

This is a phase I mechanistic study of sixty 21-40 and >65 year old adult volunteers who previously participated in vaccine studies with our program. All participation is by invitation only. The volunteers will be enrolled into two groups. Group A: Up to 30 healthy adult volunteers age 21-40 who will be given seasonal quadrivalent inactivated influenza vaccine (IIV4) prior to flu season for each of 5 years. They will also be given an inactivated Hepatitis A vaccine in the spring of years 1 and 2. Each volunteer will complete a total of 4 visits for each immunization: Day 0 (pre-immunization), Day 6-8, Day 12-15, and Day 26-30 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs). A subset of this group will be randomized to receive either a Typhoid Vi Polysaccharide Vaccine or Typhoid Vaccine Live Oral Ty21a vaccine in year 3. Each volunteer will complete a total of 4 visits for this immunization: Day 0 (pre-immunization), Day 6-8 post completion of injection or final oral dose, Day 12-15 and Day 26-30 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs). Group B: Up to 30 healthy adult volunteers age 65 plus who will be randomized and given seasonal trivalent high dose inactivated influenza vaccine (IIV3) or trivalent adjuvanted trivalent inactivated influenza vaccine (Fluad) prior to flu season for each of 5 years. They will also be given an inactivated Hepatitis A vaccine in the spring of years 1 and 2 and aTyphoid Vi Polysaccharide Vaccine in year 3. Each volunteer will complete a total of 4 visits for each immunization: Day 0 (pre-immunization), Day 6-8, Day 12-15, and Day 26-30 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs). A subset of subjects (with a target of 10 younger and 10 older subjects depending on health), will undergo bone marrow aspirates one or two years after typhoid vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Hepatitis A, Typhoid, Healthy Adults

Keywords

Inactivated, quadrivalent influenza vaccine, Inactivated Hepatitis A vaccine, Inactivated, trivalent high-dose influenza vaccine, Typhoid Vi Polysaccharide Vaccine, Typhoid Vaccine Live Oral Ty21a, Influenza Vaccine, Adjuvanted

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A IIV4

Arm Type

Experimental

Arm Description

Arm Title

Group B High Dose IIV3

Arm Type

Experimental

Arm Description

Arm Title

Group B Fluad

Arm Type

Experimental

Arm Description

Arm Title

Group A Hepatitis A (HepA)

Arm Type

Experimental

Arm Description

Arm Title

Group B Hepatitis A

Arm Type

Experimental

Arm Description

Arm Title

Group A Typhoid VI

Arm Type

Experimental

Arm Description

Arm Title

Group A Oral Typhoid

Arm Type

Experimental

Arm Description

Arm Title

Group B Typhoid VI

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Fluzone® quadrivalent

Other Intervention Name(s)

IIV4 inactivated influenza vaccine

Intervention Description

IIV4 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by intramuscular (IM) injection into the deltoid muscle.

Intervention Type

Biological

Intervention Name(s)

Fluzone High Dose

Other Intervention Name(s)

High Dose Trivalent, inactivated influenza vaccine (TIV)

Intervention Description

High Dose IIV3 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.

Intervention Type

Biological

Intervention Name(s)

Fluad

Other Intervention Name(s)

Adjuvanted Trivalent, inactivated influenza vaccine

Intervention Description

Fluad vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.

Intervention Type

Biological

Intervention Name(s)

Vaqta

Other Intervention Name(s)

Inactivated Hepatitis A Vaccine

Intervention Description

Vaqta vaccine will be administered as a 1 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.

Intervention Type

Biological

Intervention Name(s)

Typhim Vi

Other Intervention Name(s)

Typhoid Vi Polysaccharide Vaccine

Intervention Description

Typhim Vi vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.

Intervention Type

Biological

Intervention Name(s)

Vivotif

Other Intervention Name(s)

Typhoid Vaccine Live Oral Ty21a

Intervention Description

One capsule is to be swallowed approximately 1 hour before a meal with a cold or luke-warm [temperature not to exceed body temperature, e.g., 37 °C (98.6 °F)] drink on alternate days, e.g., days 1, 3, 5 and 7.

Primary Outcome Measure Information:

Title

hemagglutination inhibition assay (HAI) titers

Description

HAI titers measured at Days 0 and 28 for influenza.

Time Frame

Day 0 to Day 28

Secondary Outcome Measure Information:

Title

related AEs occurring during the 28 days post vaccination

Description

related AEs occurring during the 28 days post vaccination for each of the vaccination types (Influenza, Hepatitis A, Typhoid)

Time Frame

Day 0 to Day 28 post-each immunization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study. Prior participant in either the Ellison cohort or another Stanford vaccine study with archived samples. Male or female, aged 18-40 years or 65 years and older. In good general health as evidenced by medical history. Exclusion Criteria: Prior off-study vaccination with the current season influenza vaccine for influenza vaccinations. Allergy to egg or egg products Allergy to vaccine components, including thimerosal Active systemic or serious concurrent illness, including febrile illness on the day of vaccination Receipt of blood or blood products within the past 6 months of any study vaccination or planned receipt of blood products prior to completion of Day 28 post-immunization visit. Receipt of inactivated vaccine 14 days prior to study vaccination or planned vaccination prior to Day 28 after study vaccination. Receipt of live, attenuated vaccine within 60 days of study vaccination or planned vaccination prior to Day 28 after study vaccination. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned blood donation prior to Day 28 after study vaccination. Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of all study visits. Need for allergy immunizations (that cannot be postponed) between Days 0 and 28 post-immunization. Pregnant or lactating woman for all but influenza vaccine. A woman who is pregnant or breastfeeding may be evaluated by the Protocol Director to determine if influenza vaccination would affect volunteer safety and may be included at the discretion of the investigator. Blood sample collection will be adjusted as necessary for volunteer safety (e.g. blood collection volume for a pregnant woman would follow the minimal risk guidelines of 50 ml in an 8 week period and collection may not occur more frequently than 2 times per week). Any condition, which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Boyd, MD, PhD

Organizational Affiliation

Stanford School of Medicine, Dept. of Pathology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cornelia Dekker, MD

Organizational Affiliation

Stanford School of Medicine, Dept. of Pediatrics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford LPCH Vaccine Program

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique identification code and the volunteer identity (except for age) will not be disclosed.

IPD Sharing Time Frame

De-identified data will be loaded into ImmPort following completion of all data analysis

IPD Sharing Access Criteria

De-identified data will be publicly available through ImmPort

Learn more about this trial

Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort

We'll reach out to this number within 24 hrs