Needle-free Jet Injection of Reduced-dose, Intradermal, Influenza Vaccine in >= 6 to < 24-month-old Children

NCT00386542 | Completed Phase 1 DMC

• 1 other identifier: CDC-ISO-4785
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This is a sequential phase I and II, controlled, double-blinded study to determine whether immune responses suggesting protection against influenza can safely be induced in young children by two reduced doses one month apart of 0.1 mL of a trivalent inactivated influenza vaccine (INF) administered by the intradermal (ID) route with an investigational ID spacer on a United States (U.S.)-licensed needle-free jet injector (JI), compared to two standard intramuscular (IM) 0.25 mL doses by needle-syringe (N-S) in this age group. The locale is a developing country where financial restraints for the use of full-dose influenza vaccine would limit protection from an influenza pandemic threat, where N-Ss pose dangers and drawbacks in clinical use, and where Mantoux-type N-S ID injections are difficult to administer during mass campaigns.

Conditions

Influenza

Keywords

vaccination; influenza vaccine; jet injection; intradermal injection; infancy; children; dose-sparing; cutaneous vaccination; Dominican Republic; pandemic preparedness; jet injector; reduced dosage; immunogenicity; reactogenicity; safety; needle-free; immune response; hemagglutination inhibition; Infant

Outcome Measures

Primary Outcomes (1)

• Rates of seroconversion (SC) on HI assay 1 month after dose 2. SC defined as titer >= 40 among initial-seronegatives (titer < 8 on day 0); OR, a followup titer which rises >= 4-fold.

  seroconversion and safety assessed through occurrence of local and systemic reactions

  One month after each of doses 1 and 2.

Secondary Outcomes (4)

• Rates of local and systemic reactions

  Up to 42 days for prompted symptoms after investigational doses 1 and 2. Up to 6 months for unsolicited ones.

• Seroprotection (SP) on HI assay, defined as >= 40 regardless of baseline

  One month after each of doses 1 and 2.

• Geometric mean titers (GMT) on HI

  One month after each of doses 1 and 2.

• Geometric mean increase (GMI) on HI

  One month after each of doses 1 and 2.

Study Arms (3)

ID-JI-0.1

EXPERIMENTAL

Group "ID-JI-0.1" (n = 16) - reduced 0.1 mL INF doses administered intradermally (ID) by needle-free jet injector (JI) (Biojector® 2000 subcutaneous syringe no. 2 \[green color code\], with 2 cm investigational spacer, Bioject Medical Technologies, Inc., Portland, OR, USA)

Biological: Vaxigrip® trivalent inactivated influenza vaccine; Device: Intradermal spacer on Biojector® 2000 jet injector

IM-NS-0.1

ACTIVE COMPARATOR

Group "IM-NS-0.1" (n = 16) - reduced 0.1 mL INF doses administered intramuscularly (IM) needle-syringe (NS) (via 22-25 gauge needle, minimum 25 mm/1-inch length)

Biological: Vaxigrip® trivalent inactivated influenza vaccine

IM-NS-0.25 control

ACTIVE COMPARATOR

Group "IM-NS-0.25" (controls) (n = 16) - full 0.25 mL INF doses administered intramuscularly (IM) by needle-syringe (NS) (22-25 gauge needle, minimum 25 mm/1-inch length)

Biological: Vaxigrip® trivalent inactivated influenza vaccine

Interventions

Vaxigrip® trivalent inactivated influenza vaccine BIOLOGICAL

See full description elsewhere in this record.

ID-JI-0.1; IM-NS-0.1; IM-NS-0.25 control

Intradermal spacer on Biojector® 2000 jet injector DEVICE

See elsewhere in this record for full description.

ID-JI-0.1

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age from \> = 6 to \< 24 months (not having reached 2nd birthday).
• Born after a full-term (≥ 37 weeks), and birth weight of \>= 2.5 kg (\>= 5 pounds, 8 ounces)
• History of prior or first attendance as a patient, or as a sibling of a patient, seeking routine immunization or other clinical care at the Hospital Infantíl Robert Reid Cabral (HIRRC)
• The parent(s) or legal guardian(s) provide(s) written informed consent and agree(s) to bring the infant back to the clinic for all visits scheduled in the study
• Up-to-date for routine doses of vaccines officially recommended for the patient's age in the Dominican Republic to prevent tuberculosis, polio, diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae B
• In good health, as determined by medical history and physical examination collected in accordance with the Case Report Form (CRF), and by the clinical judgment of the investigators.

You may not qualify if:

• Infants WHOSE PARENT(S)/LEGAL GUARDIAN(S):
• Are unable or unwilling to give written informed consent for their infant to participate in the study
• Cannot be contacted by telephone (family's own or a neighbor's) if necessary for adverse events if scheduled followup return appointments are missed
• INFANTS who:
• Have fever (by parental report or by rectal temperature ≥ 38.5° C or axillary ≥ 38.0° C) currently or within the past 3 days, or who are currently suffering from an acute or chronic infectious disease (including known HIV)
• Have had an acute or chronic infection requiring systemic antimicrobial therapy (antibiotic or antiviral) or other prescribed treatment within the past 21 days. This includes any underlying illness that may limit their response to vaccination, such as those receiving intravenous immunoglobulin for agammaglobulinemia, or systemic steroid therapy.
• Are malnourished, defined by weight less than two standard deviations below the median weight for their age
• Are allergic to eggs, or have a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations, or have allergy or hypersensitivity to any component of the study vaccine
• Have ever previously received any influenza vaccine
• Have received within the prior 28 days, or for whom there is the indication to receive in the next 56 days, any non-study vaccination or investigational agent outside of the study
• Have a known bleeding diathesis, or any condition with a prolonged bleeding time
• Currently have any serious confirmed or suspected disease, such as metabolic, cardiac, or autoimmune disease, or diabetes
• Have a history of epilepsy or a seizure disorder, or neurodevelopmental disorders such as autism
• Have a genetic anomaly or known cytogenic disorder (e.g., Down's syndrome)
• Have leukemia, lymphoma, or any other cancer/neoplasm

Sponsors & Collaborators

• Pedro Moro: lead
• Fundación Dominicana de Infectología, Santo Domingo, Dominican Republic: collaborator
• Hospital Infantil Dr. Robert Reid Cabral: collaborator
• World Health Organization: collaborator
• Pan American Health Organization: collaborator
• PATH: collaborator
• Bioject Medical Technologies, Inc.: collaborator
• MCM Vaccines B.V.: collaborator

Study Sites (1)

Hospital Infantíl Dr. Robert Reid Cabral

Santo Domingo, Nacional, 2, Dominican Republic

Location

Related Publications (1)

• Palomeque FS, Weniger BG, Jet-Injected Cutaneous Influenza Vaccination Study Group. History and Technologies for Cutaneous Influenza Vaccination; and Preliminary Results from a CDC Trial of Jet-Injected, Needle-free Influenza Vaccine in ≥6 to <24-month-old Children in the Dominican Republic. CDC Vaccine Technology Seminar Series & CDC Influenza Division Seminar Series (Centers for Disease Control and Prevention), Atlanta, GA, 24 September 2013

  RESULT

Related Links

• Palomeque FS, Weniger BG, Jet-Injected Cutaneous Influenza Vacc. Study Group. Hist. \& Technol. Cutaneous Influenza Vaccin.; \& Prelim. Results CDC Trial Jet-Injected, Needle-free Infl. Vacc. ≥6-\<24-mos-olds in Dom. Rep. (CDC Presentation)

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruce G Weniger, MD, MPH

  CDC (bgweniger@siamlotus.com) (bgw2@cdc.gov obsolete by 2021).com)

  PRINCIPAL INVESTIGATOR

• Virgen Gómez, MD

  Hospital Infantíl Dr. Robert Reid Cabral

  STUDY DIRECTOR

• Jesús M Feris Iglesias, MD

  Hospital Infantíl Dr. Robert Reid Cabral

  STUDY DIRECTOR

• Josefina Fernández, MD

  Hospital Infantíl Dr. Robert Reid Cabral

  STUDY DIRECTOR

• Pedro Moro, MD, MPH

  Immunization Safety Office, Centers for Disease Control and Prevention

  STUDY DIRECTOR

• Martin Friede, PhD

  Initiative for Vaccine Research, World Health Organization

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: epidemiologist

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 11, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: May 1, 2010
• Last Updated: August 5, 2024

Record last verified: 2024-07

Locations

DO (1)