H7N9 Boost in Healthy Adults

NCT02586792 | Completed Phase 2

• 3 other identifiers: 13-0044Daughter study of 07-0023HHSN272200800002C
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be an open-label phase 2 clinical trial of a single dose of an inactivated H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the previous study healthy adults 18 to 40 years old were randomized to receive two doses, 28 days apart, of placebo or 7.5, 15, 45, or 90 ug of the influenza vaccine by IM injection in a 1:1 ratio (N=25/vaccine group and 25 in placebo group). The primary objectives are to 1) assess the safety and reactogenicity of a single dose A/H7N9 vaccine in individuals who previously received two IM doses of an A/H7N7 vaccine or are A/H7 vaccine-naïve and 2) To assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9 approximately 28 days following receipt of a single dose of A/H7N9 vaccine in individuals who previously received two IM doses of A/H7N7 vaccine or are A/H7 vaccine-naïve.

Conditions

Influenza

Keywords

Influenza,Open-Label, Vaccine, Intramusclar, H7N7, H7N9, Non-adjuvanted, sub-study

Outcome Measures

Primary Outcomes (4)

• Percent achieving HAI seroconversion against A/H7N9 antigen in A/H7N9 vaccine defined as either pre-vaccine HAI titer <1:10 and post-vaccine HAI titer > /= 1:40 or pre-vaccine HAI titer > /= 1:10 and minimum 4-fold rise in post-vaccine HAI antibody titer

  Approximately 28 days after the A/H7N9 study vaccination.

• Occurrence of solicited injection site and systemic reactogenicity events.

  Time of the A/H7N9 study vaccination through 8 days after the A/H7N9 study vaccination.

• Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the A/H7N9 study vaccine.

  Approximately 28 days after the A/H7N9 study vaccination.

• Occurrence of study vaccine-related serious adverse events.

  Time of the A/H7N9 study vaccination through approximately 6 months after the A/H7N9 study vaccination

Secondary Outcomes (7)

• Percent achieve Neut seroconversion against A/H7N9 antigen in A/H7N9 vaccine, defined as either pre-vaccine Neut titer <1:10 and post-vaccine Neut titer > /= 1:40 or pre-vaccine Neut titer > /= 1:10 and min 4-fold rise in post-vaccine Neut antibody titer

  Approximately 8 and 28 days after the A/H7N9 study vaccination.

• Occurrence of study vaccine-related unsolicited non-serious adverse events.

  Time of the A/H7N9 study vaccination through approximately 28 days after the A/H7N9 study vaccination.

• Percentage of subjects achieving HAI seroconversion against the A/H7N9 antigen contained in the A/H7N9 study vaccine.

  Approximately 8 days after A/H7N9 the study vaccination.

• Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the A/H7N9 study vaccine.

  At baseline and approximately 8 days after the A/H7N9 study vaccination.

• Percentage of subjects achieving a serum Neut antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the A/H7N9 study vaccine.

  At baseline and approximately 8 and 28 days after the A/H7N9 study vaccination.

Study Arms (2)

Group 2

EXPERIMENTAL

N up to 10 in prior receipt of a placebo in DMID Protocol 07-0023 will receive 45 mcg of HA/0.75 ml of Monovalent inactivated influenza A/H7N9 virus vaccine

Biological: Monovalent influenza A/H7N9 virus vaccine

Group 1

EXPERIMENTAL

N up to 40 in prior receipt of a monovalent inactivated influenza A/H7N7 virus vaccine in DMID Protocol 07-0023 will receive 45 mcg of HA/0.75 ml of Monovalent inactivated influenza A/H7N9 virus vaccine

Biological: Monovalent influenza A/H7N9 virus vaccine

Interventions

Monovalent influenza A/H7N9 virus vaccine BIOLOGICAL

Monovalent influenza A/H7N9 virus vaccine.

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent prior to initiation of any study procedures.
• Are able to understand and comply with planned study procedures and be available for all study visits.
• Are males or non-pregnant females, 19 to 50 years old, inclusive.

You may not qualify if:

• Oral temperature is less than 100.0F.
• Pulse is 50 to 115 bpm, inclusive.
• Systolic blood pressure is 85 to 150 mmHg, inclusive.
• Diastolic blood pressure is 55 to 95 mmHg, inclusive.
• Women of childbearing potential\*\* in sexual relationships with men must use an acceptable method of preventing conception\*\*\* from 30 days prior to 60 days after the study vaccination.
• \*\*Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year of the last menses if menopausal.
• \*\*\*Includes, but is not limited to, sexual abstinence, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill).
• Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to the study vaccination.
• Received either two doses of an inactivated influenza A/H7N7 vaccine or one or two doses of placebo in DMID Protocol 07-0023 or have not received an influenza A/H7 vaccine.
• Have an acute illness\*, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to the study vaccination.
• \* An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation\*\*.
• \*\*Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study.
• Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to the study vaccination.
• Have known active neoplastic disease or a history of any hematologic malignancy. Nonmelanoma skin cancers are permitted.

Sponsors & Collaborators

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

Study Sites (1)

Baylor College of Medicine - Molecular Virology and Microbiology

Houston, Texas, 77030-3411, United States

Location

Related Publications (1)

• El Sahly HM, Atmar RL, Patel SM, Bellamy A, Liu L, Hong W, Zhu H, Guan Y, Keitel WA; DMID 13-0033 Vaccine Study Group. Safety and immunogenicity of an 8 year interval heterologous prime-boost influenza A/H7N7-H7N9 vaccination. Vaccine. 2019 May 1;37(19):2561-2568. doi: 10.1016/j.vaccine.2019.03.071. Epub 2019 Apr 4.

  PMID: 30955980 DERIVED

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 26, 2015
• Study Start: January 12, 2016
• Primary Completion: December 29, 2016
• Study Completion: December 29, 2016
• Last Updated: August 22, 2018

Record last verified: 2016-04

Locations

US (1)