Respiratory Syncytial Virus InfectionsPhase 1NCT02601612
Safety and Immunogenicity of the RSV D46cpΔM2-2 Vaccine in RSV-Seropositive Children and RSV-Seronegative Infants and Children
A Phase 1 study testing D46cpΔM2-2 vaccine in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children. Read more about this study
- Who is it for?
- Ages 6 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- D46cpΔM2-2 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 26 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Greater than or equal to 12 months of age and less than 60 months of age
- Received routine immunizations appropriate for age
- Serum RSV neutralizing antibody titer greater than or equal to 1:40
- Serum RSV neutralizing antibody result obtained this calendar year
- Pre-inoculation serum RSV neutralizing antibody specimen obtained less than or equal to 56 days prior to inoculation
- Parent/guardian has completed the study comprehension assessment
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- Parent/guardian has signed the study informed consent document (ICD)
- Subject is expected to be available for the duration of the study
- Greater than or equal to 6 months of age and less than 25 months of age
- Received routine immunizations appropriate for age
- Serum RSV neutralizing antibody titer is less than 1:40
- Screening and pre-inoculation serum RSV neutralizing antibody specimen obtained less than or equal to 42 days prior to inoculation
- Parent/guardian has completed the study comprehension assessment
- Parent/guardian has signed the study ICD
- Subject is expected to be available for the duration of the study
- Born at greater than or equal to 37 weeks gestation or is currently greater than 1 year of age
Who cannot join
- Evidence of chronic disease
- Within the past 6 months had a decline in height or weight growth that crosses two major growth percentiles (e.g., from above the 75th to below the 25th)
- Known or suspected impairment of immune function
- Maternal history of positive HIV test
- Bone marrow/solid organ transplant recipient
- Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
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- Current or unresolved suspected or documented developmental disorder, delay, or other developmental problem
- Cardiac abnormality requiring treatment
- Lung disease or reactive airway disease
- More than one episode of wheezing in the first year of life
- Wheezing episode or received bronchodilator therapy within the past 12 months
- Previous immunization with an experimental RSV vaccine
- Previous receipt or planned administration of anti-RSV antibody product
- Previous serious vaccine-associated AE or anaphylactic reaction
- Known hypersensitivity to any vaccine component
- Previous receipt of immunoglobulin or any antibody products
- Previous receipt of any other blood products within the past 6 months
- Member of a household that contains an infant who is less than 12 months of age during study days 0 to 10
- Member of a household that includes an immunocompromised individual
- Member of a household that includes a person who has received chemotherapy within the past 12 months
- Will attend a daycare facility that does not separate children by age and contains an infant who is greater than 12 months of age during study days 0 to 10
- RSV-Seronegative Infants and Children:
- Evidence of chronic disease
- Within the past 6 months had a decline in height or weight growth that crosses two major growth percentiles (e.g., from above the 75th to below the 25th)
- Known or suspected impairment of immune function
- Maternal history of positive HIV test
- Bone marrow/solid organ transplant recipient
- Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
- Current or unresolved suspected or documented developmental disorder, delay, or other developmental problem
- Cardiac abnormality requiring treatment
- Lung disease or reactive airway disease
- More than one episode of wheezing in the first year of life
- Wheezing episode or received bronchodilator therapy within the past 12 months
- Previous immunization with an experimental RSV vaccine
- Previous receipt or planned administration of anti-RSV antibody product
- Previous receipt of immunoglobulin or any antibody products
- Previous receipt of any other blood products within the past 6 months
- Previous serious vaccine-associated AE or anaphylactic reaction
- Known hypersensitivity to any vaccine component
- Member of a household which contains an infant who is less than 6 months of age during study days 0 to 28
- Member of a household that includes an immunocompromised individual
- Member of a household that includes a person who has received chemotherapy within the past 12 months
- Will attend a daycare facility that does not separate children by age and contains an infant who is less than 6 months of age during study days 0 to 28
- Temporary Exclusion Criteria for RSV-Seropositive and RSV-Seronegative Children:
- To be eligible to participate, RSV-seropositive and RSV-seronegative infants and children must satisfy none of the temporary exclusion criteria. The following conditions are temporary or self-limiting. Once the condition is resolved and the subject is otherwise eligible, the subject may be enrolled or rescreened, if necessary.
- Any of the following events at the time of inoculation:
- fever (rectal temperature of greater than or equal to 100.4°F),
- upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis)
- nasal congestion significant enough to interfere with successful inoculation
- otitis media
- Receipt of any killed vaccine or live-attenuated rotavirus vaccine less than 14 days prior to inoculation
- Receipt of the following medications less than 28 days prior to inoculation:
- any live vaccine other than rotavirus
- another investigational vaccine or investigational drug,
- systemic corticosteroids administered for greater than 14 days at a dosage equivalent to prednisone at greater than 2 mg/kg or 20 mg daily
- salicylate (aspirin) or salicylate-containing products
- Receipt of a non-permitted concomitant medication or any of the following medications less than 3 days prior to inoculation:
- systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis,
- intranasal medications
- Scheduled administration of the following in relation to planned inoculation:
- killed vaccine within the 14 days following,
- any live vaccine other than rotavirus within the 28 days following,
- another investigational vaccine or drug within the 28 days following for RSV-seropositive children and the 56 days following for RSV-seronegative infants and children
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Live Recombinant RSV D46cpΔM2-2 Vero Grown Virus Vaccine (Lot RSV #008A), Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age and RSV-Seronegative Infants and Children 6 to 24 Months of Age
The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children.
Read the detailed description
Human RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study will evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children. The vaccine will be evaluated in a stepwise fashion beginning in RSV-seropositive children (Group 1), and then in RSV-seronegative infants and children (Group 2). In each group, participants will be randomly assigned to receive a single dose of D46cpΔM2-2 vaccine or placebo at study entry (day 0).
Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season. Group 1 (RSV-seropositive children) will attend several study visits and will be followed for 28 days. Group 2 (RSV-seronegative infants and children) will remain on study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Participants in Group 2 will also attend several study visits during the time they are enrolled in the study. Study visits for all participants may include clinical assessments, blood collection, and nasal washes.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- D46cpΔM2-2 vaccine, Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D46cpΔM2-2 vaccineBiological
Delivered as nose drops
PlaceboBiological
Delivered as nose drops
| Study group | Role | What they receive |
|---|---|---|
| Group 1: D46cpΔM2-2 Vaccine | Experimental | RSV-seropositive children will receive a single dose of 10^6 PFU D46cpΔM2-2 vaccine at study entry (day 0). Receives: Biological: D46cpΔM2-2 vaccine |
| Group 1: Placebo | Placebo comparator | RSV-seropositive children will receive a single dose of placebo at study entry (day 0). Receives: Biological: Placebo |
| Group 2: D46cpΔM2-2 Vaccine | Experimental | RSV-seronegative infants and children will receive a single dose of 10^5 PFU D46cpΔM2-2 vaccine at study entry (day 0). Receives: Biological: D46cpΔM2-2 vaccine |
| Group 2: Placebo | Placebo comparator | RSV-seronegative infants and children will receive a single dose of placebo at study entry (day 0). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study
Measured: Measured at days 0-10 for seropositive and days 0-28 for seronegative
Severity of vaccine-related solicited AEs that occur during the acute monitoring phase of the study
Measured: Measured at days 0-10 for seropositive and days 0-28 for seronegative
Frequency of vaccine-related lower respiratory illness
Measured: Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects
Proportion of subjects shedding vaccine virus
Measured: Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects
Proportion of subjects that develop 4-fold or greater increases in RSV neutralizing antibody titer following vaccination
Measured: Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startOct 2015
- Primary completion26 Apr 2018
- Study completion26 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ruth A. Karron, MD, Principal investigator, Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601612
- Sponsor's protocol ID
- CIR 308
- Status last verified
- Sep 2024
- First submitted
- 9 Nov 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karron RA, Woods S, Wanionek K, Oliva J, Yang L, Luongo C, Collins PL, Buchholz UJ. Live Respiratory Syncytial Virus Vaccine D46/cp/DeltaM2-2 Is Overattenuated in RSV-Seronegative Children. Open Forum Infect Dis. 2026 Jul 29;13(8):ofag388. doi: 10.1093/ofid/ofag388. eCollection 2026 Aug.
PubMed 42549136
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Live Recombinant RSV D46cpΔM2-2 Vero Grown Virus Vaccine (Lot RSV #008A), Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age and RSV-Seronegative Infants and Children 6 to 24 Months of Age
- ClinicalTrials.gov ID
- NCT02601612
- Acronym / sponsor ID
- CIR 308
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2015
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children.
Detailed description
Human RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study will evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children. The vaccine will be evaluated in a stepwise fashion beginning in RSV-seropositive children (Group 1), and then in RSV-seronegative infants and children (Group 2). In each group, participants will be randomly assigned to receive a single dose of D46cpΔM2-2 vaccine or placebo at study entry (day 0).
Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season. Group 1 (RSV-seropositive children) will attend several study visits and will be followed for 28 days. Group 2 (RSV-seronegative infants and children) will remain on study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Participants in Group 2 will also attend several study visits during the time they are enrolled in the study. Study visits for all participants may include clinical assessments, blood collection, and nasal washes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: D46cpΔM2-2 Vaccine | Experimental | Biological: D46cpΔM2-2 vaccineRSV-seropositive children will receive a single dose of 10^6 PFU D46cpΔM2-2 vaccine at study entry (day 0). |
| Group 1: Placebo | Placebo comparator | Biological: PlaceboRSV-seropositive children will receive a single dose of placebo at study entry (day 0). |
| Group 2: D46cpΔM2-2 Vaccine | Experimental | Biological: D46cpΔM2-2 vaccineRSV-seronegative infants and children will receive a single dose of 10^5 PFU D46cpΔM2-2 vaccine at study entry (day 0). |
| Group 2: Placebo | Placebo comparator | Biological: PlaceboRSV-seronegative infants and children will receive a single dose of placebo at study entry (day 0). |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Greater than or equal to 12 months of age and less than 60 months of age
- Received routine immunizations appropriate for age
- Serum RSV neutralizing antibody titer greater than or equal to 1:40
- Serum RSV neutralizing antibody result obtained this calendar year
- Pre-inoculation serum RSV neutralizing antibody specimen obtained less than or equal to 56 days prior to inoculation
Key exclusion criteria (63 listed)
- Evidence of chronic disease
- Within the past 6 months had a decline in height or weight growth that crosses two major growth percentiles (e.g., from above the 75th to below the 25th)
- Known or suspected impairment of immune function
- Maternal history of positive HIV test
- Bone marrow/solid organ transplant recipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D46cpΔM2-2 vaccineDelivered as nose drops | Biological | Group 1: D46cpΔM2-2 Vaccine, Group 2: D46cpΔM2-2 Vaccine |
| PlaceboDelivered as nose drops | Biological | Group 1: Placebo, Group 2: Placebo |
Primary outcome
Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study
Time frame: Measured at days 0-10 for seropositive and days 0-28 for seronegative
Severity of vaccine-related solicited AEs that occur during the acute monitoring phase of the study
Time frame: Measured at days 0-10 for seropositive and days 0-28 for seronegative
Frequency of vaccine-related lower respiratory illness
Time frame: Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects
Proportion of subjects shedding vaccine virus
Time frame: Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects
Proportion of subjects that develop 4-fold or greater increases in RSV neutralizing antibody titer following vaccination
Time frame: Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42549136Karron RA, Woods S, Wanionek K, Oliva J, Yang L, Luongo C, Collins PL, Buchholz UJ. Live Respiratory Syncytial Virus Vaccine D46/cp/DeltaM2-2 Is Overattenuated in RSV-Seronegative Children. Open Forum Infect Dis. 2026 Jul 29;13(8):ofag388. doi: 10.1093/ofid/ofag388. eCollection 2026 Aug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth A. Karron, MD principal investigator
Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D46cpΔM2-2 vaccine in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 63 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (time frame: Measured at days 0-10 for seropositive and days 0-28 for seronegative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02601612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.