NCT01534468

Evaluation of Priming by Pandemic Live Attenuated Influenza Vaccine (LAIV) on the Subsequent Response to Inactivated H7N7 Vaccine in Healthy Adults: A Non-Randomized, Open Label Study

Completed Phase 1 Last updated 14 December 2015

What this trial tests

Phase 1 trial testing Monovalent Influenza Subvirion Vaccine, H7N7 in Influenza A Subtype H7N7 Infection in 45 participants. Completed in 1 March 2014.

Timeline

1 March 2012

Primary endpoint
1 March 2014

1 March 2014

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	45
Start date	1 March 2012
Primary completion	1 March 2014
Estimated completion	1 March 2014
Sites	1 location across United States

Drugs / interventions tested

• Monovalent Influenza Subvirion Vaccine, H7N7 — full drug profile →

Conditions studied

• Influenza A Subtype H7N7 Infection — all drugs for Influenza A Subtype H7N7 Infection →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with Influenza A Subtype H7N7 Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Frequency of vaccine-related reactogenicity events that occur during the acute monitoring phase of the study
  Time frame: Measured through Day 7
• Development of serum antibody assessed by either hemagglutination inhibition (HAI) or micronucleus (MN) assays
  Time frame: Measured through Day 180

Sponsor's own description

H7N7 is one type of influenza virus that may pose a threat to humans if an outbreak occurs. This study will evaluate the safety and immune response to an H7N7 vaccine in people who have previously received a live attenuated influenza vaccine (LAIV) as part of a research study and people who have not previously received a LAIV.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Broadly-Reactive Neutralizing and Non-neutralizing Antibodies Directed against the H7 Influenza Virus Hemagglutinin Reveal Divergent Mechanisms of Protection.
   Tan GS, Leon PE, Albrecht RA, Margine I, et al · · 2016 · cited 127× · PMID 27081859 · DOI 10.1371/journal.ppat.1005578
2. Live attenuated H7N7 influenza vaccine primes for a vigorous antibody response to inactivated H7N7 influenza vaccine.
   Babu TM, Levine M, Fitzgerald T, Luke C, et al · · 2014 · cited 63× · PMID 25446831 · DOI 10.1016/j.vaccine.2014.09.070
3. Divergent H7 immunogens offer protection from H7N9 virus challenge.
   Krammer F, Albrecht RA, Tan GS, Margine I, et al · · 2014 · cited 46× · PMID 24453375 · DOI 10.1128/jvi.03095-13
4. High-Affinity H7 Head and Stalk Domain-Specific Antibody Responses to an Inactivated Influenza H7N7 Vaccine After Priming With Live Attenuated Influenza Vaccine.
   Halliley JL, Khurana S, Krammer F, Fitzgerald T, et al · · 2015 · cited 38× · PMID 25838266 · DOI 10.1093/infdis/jiv210
5. Development of Nasal Vaccines and the Associated Challenges.
   Nian X, Zhang J, Zhang J, Huang S, et al · · 2022 · cited 33× · PMID 36297419 · DOI 10.3390/pharmaceutics14101983
6. Nanoplatform Based Intranasal Vaccines: Current Progress and Clinical Challenges.
   Bai Z, Wan D, Lan T, Hong W, et al · · 2024 · cited 14× · PMID 39185745 · DOI 10.1021/acsnano.3c10797