Effects of Aging on Primary and Secondary Vaccine Responses

NCT03312699 | Completed Phase 1 FDA Drug

• 2 other identifiers: 40216R01AI130398-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• hemagglutination inhibition assay (HAI) titers

  HAI titers measured at Days 0 and 28 for influenza.

  Day 0 to Day 28

Secondary Outcomes (1)

• related AEs occurring during the 28 days post vaccination

  Day 0 to Day 28 post-each immunization

Study Arms (8)

Group A IIV4

EXPERIMENTAL

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).

Biological: Fluzone® quadrivalent

Group B High Dose IIV3

EXPERIMENTAL

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).

Biological: Fluzone High Dose

Group B Fluad

EXPERIMENTAL

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).

Biological: Fluad

Group A Hepatitis A (HepA)

EXPERIMENTAL

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).

Biological: Vaqta

Group B Hepatitis A

EXPERIMENTAL

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).

Biological: Vaqta

Group A Typhoid VI

EXPERIMENTAL

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).

Biological: Typhim Vi

Group A Oral Typhoid

EXPERIMENTAL

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).

Biological: Vivotif

Group B Typhoid VI

EXPERIMENTAL

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).

Biological: Typhim Vi

Interventions

Fluzone® quadrivalent BIOLOGICAL

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.

Also known as: IIV4 inactivated influenza vaccine

Group A IIV4

Fluzone High Dose BIOLOGICAL

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.

Also known as: High Dose Trivalent, inactivated influenza vaccine (TIV)

Group B High Dose IIV3

Fluad BIOLOGICAL

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.

Also known as: Adjuvanted Trivalent, inactivated influenza vaccine

Group B Fluad

Vaqta BIOLOGICAL

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

Also known as: Inactivated Hepatitis A Vaccine

Group A Hepatitis A (HepA); Group B Hepatitis A

Typhim Vi BIOLOGICAL

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.

Also known as: Typhoid Vi Polysaccharide Vaccine

Group A Typhoid VI; Group B Typhoid VI

Vivotif BIOLOGICAL

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.

Also known as: Typhoid Vaccine Live Oral Ty21a

Group A Oral Typhoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Stanford LPCH Vaccine Program

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Influenza, Human; Hepatitis A; Typhoid Fever

Interventions

Fluzone High-Dose; fluad vaccine; Hepatitis A Vaccines; Vi polysaccharide vaccine, typhoid; Ty21a typhoid vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Scott Boyd, MD, PhD

  Stanford School of Medicine, Dept. of Pathology

  PRINCIPAL INVESTIGATOR

• Cornelia Dekker, MD

  Stanford School of Medicine, Dept. of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Infectious Diseases)

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 18, 2017
• Study Start: September 19, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified data will be loaded into ImmPort following completion of all data analysis
• Access Criteria: De-identified data will be publicly available through ImmPort

Locations

US (1)