Nasal vaccine could shield newborns from whooping cough
NCT ID NCT01188512
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new whooping cough vaccine given as a nasal spray. 48 healthy adult men received either the vaccine or a placebo to check safety and immune response. The goal is to develop a single-dose vaccine that can protect infants from birth, before they get their regular shots.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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48 people
The number who actually took part.
- Start date
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Aug 2010
- Finished
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Jan 2012
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 31 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subject will be included in the study if he meets all the following criteria: * Healthy male born between 1979 and 1991 who has not experienced clinical pertussis (lab. Verified) during the past 10 years and who has not been vaccinated with any pertussis vaccine. * Informed consent form signed by the subject. * Subject shall be able to attend all scheduled visits and to understand and comply with the study procedures (e.g. able to read and write Swedish). Exclusion Criteria: If any of the following criteria are met, the subject must not be included in the study: * Individuals with pertussis toxin serum IgG antibodies ≥20 units/mL. * Blood pressure after resting ≥ 150/90 mmHg. * Heart rate after resting ≥80 bpm. * Respiratory rate after resting ≥ 20/minute. * Unwillingness to refrain from the use of nicotine products from screening through day 28. * Use of narcotic drugs/alcohol and/or a history of previous use of drug/alcohol abuse whitin the past 2 years prior to screening * The subject has donated blood or suffered from blood loss of at least 450 ml (1 unit of blood) within 60 days prior to screening or donated plasma within 14 days prior to screening. * Receipt of immunoglobulin, blood derived products, systemic corticosteroids or other immunosuppressant drugs within 90 days prior to day 0. * Use of corticosteroids in the respiratory tract(e.g. nasal steroids, inhaled steroids) whitin 30 days prior to day 0. * Use of herbal medications or dietary supplements within 7 days prior to day 0 at the discretion of the investigator. Unwillingness to refrain from herbal medications or dietary supplements within 30 days after day 0 at the discretion of the investigator. * Receipt of a vaccine within the last 30 days prior to day 0 or planned vaccination within the next 30 days after day 0. * Evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine. * Known hypersensitivity to any component of the study vaccine. * Current participation in any other clinical trial or participation (and during the whole study) in any clinical trial in the previous 3 months prior to day 0. * Inability to adhere to the protocol, including plans to move from the area. * Family history of congenital or hereditary immunodeficiency (first degree). * Infection with HIV, hepatitis B or C. * Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. * Clinically significant abnormal laboratory values at the discretion of the investigator. * Person in frequent contact with children less than 1 year of age (father, childcare worker, nurse, etc…) or residence in the same household as persons with known immunodeficiency.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Karolinska University Hospital
Solna, 171 76, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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