Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years

NCT01928472 | Completed Phase 1 Results

• 1 other identifier: V131_01
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 6

Brief Summary

Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.

Conditions

H7N9 Influenza

Keywords

Influenza, H7N9, Vaccine

Outcome Measures

Primary Outcomes (7)

• Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)

  Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination

  Day 1 and 43

• Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)

  Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.

  Day 43

• Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)

  Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination. Seroconversion is defined as postvaccination HI titer\> 40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum 4-fold increase in titer for subjects with baseline titer \>1:10.

  Day 43

• Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)

  Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.

  Day 1 and 43

• Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine

  Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.

  Day 1 to Day 43

• Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine

  The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.

  Day 1 to Day 366.

• Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine

  Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.

  Day 1 through Day 7 after each vaccination.

Secondary Outcomes (8)

• Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)

  Day 1 and 22

• Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)

  Day 22

• Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)

  Day 22

• Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)

  Day 1 and 22.

• Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)

  Day 183 and 366.

Study Arms (4)

Group A

EXPERIMENTAL

H7N9c low dose with adjuvant

Biological: H7N9c low dose with adjuvant

Group B

EXPERIMENTAL

H7N9c medium dose with adjuvant

Biological: H7N9c medium dose with adjuvant

Group C

EXPERIMENTAL

H7N9c high dose with adjuvant

Biological: H7N9c high dose with adjuvant

Group D

EXPERIMENTAL

H7N9c high dose without adjuvant

Biological: H7N9c high dose without adjuvant

Interventions

H7N9c low dose with adjuvant BIOLOGICAL

Group A

H7N9c medium dose with adjuvant BIOLOGICAL

Group B

H7N9c high dose with adjuvant BIOLOGICAL

Group C

H7N9c high dose without adjuvant BIOLOGICAL

Group D

Eligibility Criteria

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

You may qualify if:

• Healthy adult subject ages 18-64 years.
• Individuals willing to provide written informed consent
• Individuals in good health.
• Individuals who can comply with study procedures and follow-up.

You may not qualify if:

• Individuals with history of cognitive or behavioral impairment or psychiatric disease,
• Individuals unable to understand and follow study procedures,
• History of significant illness,
• History of chronic medical condition or progressive disease,
• Allergy to any vaccine component or adverse event related to a vaccine component,
• Impairment/alteration of the immune system,
• Presence of progressive or severe neurological disorder,
• Pregnant or breast-feeding,
• Female of Child-bearing potential unwilling to use acceptable method of birth control,
• Presence of medically significant cancer,
• Receipt of investigational product within 30 day prior to entry into the study,
• History of previous or suspected illness from avian flu caused by H7N9 virus,
• History of H7 vaccination,
• Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination,
• Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (6)

Site 04: Accelovance

San Diego, California, 92108, United States

Location

Site 01: Accelovance

Melbourne, Florida, 32935, United States

Location

Site 02: Accelovance

Peoria, Illinois, 61602, United States

Location

Site 03: Accelovance

Rockville, Maryland, 20850, United States

Location

Site 05: Janet Lewis

Salt Lake City, Utah, 84109, United States

Location

Site 06: Janet Lewis

Salt Lake City, Utah, 84121, United States

Location

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 26, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 11, 2019
• Results First Posted: May 21, 2015

Record last verified: 2019-05

Locations

US (6)