Ebola vaccine in a nasal spray? early trial halted
NCT ID NCT03462004
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a nasal spray vaccine against Ebola in 15 healthy adults. The vaccine uses a weakened common cold virus to deliver a piece of the Ebola virus. The study aimed to check safety and immune response, but it was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HPIV3/ΔHNF/EbovZ GP vaccine (nasal spray)
- What this could lead to
- If successful, this could lead to a needle-free Ebola vaccine that is easier to administer in outbreaks.
- What could go wrong
- This was a very early (phase 1) trial with only 15 participants, and it was terminated early, so we don't have full safety or effectiveness data. The vaccine may not produce strong enough immunity or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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15 people
The number who actually took part.
- Started
-
Mar 2018
- Finished
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Mar 2019
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
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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18 to 50 years
- Sex
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Anyone
- 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: * Adult males and non-pregnant females between 18 and 50 years of age inclusive * General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator * Agree to storage of blood specimens for future research * Available for the duration of the trial * Able to demonstrate understanding of key study concepts, study rationale, and study participation requirements by scoring greater than or equal to 70% on a written comprehension assessment in less than or equal to 3 attempts. * Willingness to participate in the study as evidenced by signing the informed consent document * Female subjects of childbearing potential must agree to have used effective birth control methods beginning at least one month prior to vaccination, and continuing with 'per label/fully effective use' for the chosen method for the duration of the study, from amongst these: * pharmacologic/hormonal contraceptives, including oral, parenteral, subcutaneous, and transcutaneous delivery; * condoms with spermicide; * diaphragm with spermicide; * intrauterine device; * absolute abstinence from heterosexual intercourse as a matter of normal preferred lifestyle; * or must be surgically sterile, or must be age 50 AND have had no menses at all for at least one full year. * All females must provide samples for urine and serum pregnancy testing prior to enrollment (immediately prior to each vaccination), as well as a statement of menstrual history and a summary of all potentially reproductive sexual activity for the month prior to each vaccination, and at each study contact throughout the study, and report if they may be pregnant immediately. * Willingness to refrain from blood donation during the course of the study * Willingness to refrain from receiving other vaccines or investigational products during the first 4 months of the study after enrollment * Willingness to follow admission and isolation requirements for the indicated duration per protocol. Exclusion Criteria: * Pregnancy as determined by a positive human choriogonadotropin (ß-HCG) test or history of recent unprotected intercourse in a woman of reproductive capacity * Currently breastfeeding * Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatological, autoimmune, or renal disease by history, physical examination, and/or laboratory studies * History of intranasal pathology or evidence of structural abnormalities of the sinuses or nasal cavity upon examination * Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the study protocol * Positive urine drug toxicology test indicating narcotic use or history of dependency * Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months * Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol. * History of anaphylaxis * Current diagnosis of asthma or reactive airway disease (within the past 2 years) * Current history of allergic rhinitis requiring the use of medication in the 2 weeks before enrollment or the first 56 days of the study * History of Bell's palsy * Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory test (e.g., Western blot or HIV-1/HIV-2 differentiation assay) for human immunodeficiency virus-1 (HIV-1) * Positive ELISA and confirmatory test (e.g., polymerase chain reaction (PCR) for virus) for hepatitis C virus (HCV) * Positive hepatitis B virus surface antigen (HBsAg) by ELISA test * Known immunodeficiency syndrome or history suggestive of impaired immune function * Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination * Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination * History of asplenia. * Body mass index (BMI) less than 18.5 or greater than 40 * Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination * Current tobacco user unwilling to refrain from smoking, snuffing, vaping, or chewing for the duration of the inpatient study (subjects may use nicotine patches if needed) * Travel to an Ebola-endemic region at the time when cases were present or planned travel to West or Central Africa during the study period * Receipt of another investigational vaccine or drug within 30 days prior to study vaccination * Previous receipt of an investigational Ebola or Marburg virus vaccine, a chimpanzee adenovirus, or human parainfluenza virus (HPIV)-vectored vaccine, or any other investigational vaccine likely to affect interpretation of the trial data * Current or past (in the last 4 weeks) user of intranasal medications (including steroids, decongestants, or hormonal medications), or planning to use them within 28 days of study vaccination * Live or have close contact with vulnerable individuals, including infants, the elderly, or immunocompromised individuals (those with HIV/AIDS, malignancy, or transplant patients) * History of Liver disease.
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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
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CIR Inpatient Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205, United States
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Other studies related to the condition(s) this trial covers.
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