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CancerIVACOVNCT05025514

Retrospective Study of COVID-19 Vaccines in Patients Undergoing Immunotherapy for Cancer.

An observational study of Cancer and Immunotherapy, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life"… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Immunotherapy
Type of treatment
Vaccines
How many people
125 participants
Where
5 sitesFrance
Study dates
19 Oct 2021to 16 Sep 2022
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of all patients with cancer requiring anti-PD, anti-PDL1 or antiCTLA4 immunotherapy for any tumour (solid, liquid) who have been vaccinated or eligible for vaccination against COVID19 (of any kind, except live, attenuated virus) and treated in the medical oncology departments of the Occitanie region.

Who may be able to join

  • Patient having been vaccinated or eligible for inoculation with one of the available anti-COVID19 vaccines (except live attenuated virus) while they were or are undergoing immunotherapy with anti-PD1, anti-PDL1 or anti-CTLA4 immunotherapy whatever the tumor (solid, liquid) managed within the medical oncology services of the Occitanie region.
  • Patients affiliated to or beneficiaries of a health insurance scheme.
  • Patients who have received written and oral information about the study and who have no objection to participation.
  • Adult patients (≥ 18 years).

Who cannot join

  • Patients who have been vaccinated with a live attenuated vaccine.
  • Patients with a contraindication to inclusion (including hypersensitivity to the active substance or to one of the excipients, COVID+ PCR test in the last 3 months).
  • Minor patients, pregnant women, parturients, nursing mothers, persons in nursing mothers, persons in emergency situations, persons unable to persons unable to express their consent and persons under persons under court protection, subguardianship or subguardianship may not be included in this research.
  • Patients in an exclusion period determined by another study.
  • Patients for whom it is impossible to give clear information.
  • Patients who have expressed an objection to participating in the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Centre Hospitalier d'Albi

    Albi

  • CH d'Auch

    Auch, 32008

  • CH de Cahors

    Cahors

  • Clinique des Cèdres - Capio

    Cornebarrieu, 31700

  • CHU de Nîmes

    Nîmes, Gard, 30029

Other trials in France

About this study

Official title: Pharmaco-epidemiological Study of COVID 19 Vaccines in Patients Undergoing Immunotherapy for Cancer. A Retrospective Open Cohort Study.

The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. The hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J \& J COVID-19 Vaccine.

Read the detailed description

The recent outbreak of Coronavirus 2019 (COVID-19) caused by a new zoonotic coronavirus SARS-Cov-2 poses a major public health threat, with at least 100,000,000 people infected worldwide by the end of January 2021 and over 2 million deaths. Given the scale of the pandemic, it has become imperative to quickly develop a vaccine and over 30 vaccine candidates have entered clinical evaluation. The first vaccine to receive marketing authorization in Europe and France was an mRNA vaccine, Comirnaty® (Bnt162b2; Pfizer/BioNtech). In a Phase III study of 43,448 participants, after a median follow-up of 2 months, the number of cases of COVID-19 was 8 in the vaccine arm vs. versus 162 in the placebo arm, respectively, with 1 versus 9 serious cases (Polack et al. 2020). Adverse events occurred in more than 50% of vaccinated participants and included local reactions as well as frequent systemic reactogenicity such as fatigue and headache. Fever occurred in about 15% of the participants who received the vaccine. The second vaccine to be licensed was also an mRNA vaccine: the Moderna COVID-19 mRNA (nucleoside modified) vaccine (mRNA-1273, Moderna). A Phase III trial involving 30,420 volunteers reported efficacy and safety comparable to the Pfizer/BioNtech vaccine. A severe form of COVID-19 occurred in 30 subjects, with one death; all 30 cases were in the placebo group. Moderate and transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group.

Serious adverse events were rare and the incidence was similar in both groups. Within the vaccination strategy implemented on a national level, the Comirnaty® vaccine (Pfizer/BioNtech) and the Moderna COVID-19 mRNA vaccine (nucleoside modified) may be used interchangeably, depending on logistical constraints.

For several weeks now, the Oxford-AstraZeneca chimpanzee adenovirus vector vaccine ChAdOx1 nCoV-19 (AZD1222) has been available in France and its efficacy and safety of use have been evaluated. Also the non-replicating viral vector (adenovirus) vaccine for CVD 19 from Janssen Laboratories (a subsidiary of Johnson \& Johnson; other names: Ad26COV2.S; JMJ Vaccine or J \& J COVID-19 Vaccine) was launched in France a few weeks ago. Its efficacy and safety have been validated in a phase III trial. A number of other candidate vaccines using various techniques such as mRNA, protein subunit, viral vector or inactivated vaccines are currently under investigation and will be available soon.

Cancer patients are particularly at risk of developing a severe form of COVID-19. Patients with solid tumors appear to be at a greater risk, particularly in the first year after diagnosis. Severity and mortality rates in the COVID-19 and Cancer Consortium (CCC19) registry and other cohorts range from 5% to 61% (a meta-analysis showed 26%), which is well above the general population. Although data on vaccination in cancer patients are limited, there is sufficient evidence to support anti-infective vaccination in general, even in cancer patients on immunosuppressive therapy. In its notice dated January 25th, 2021, the National Cancer Institute defined its recommendations for prioritizing cancer patients for vaccination against SARS-CoV-2. This report stresses that the data acquired from science is limited in quantity and quality concerning the emerging field of vaccination against SARS-CoV-2 and even more so in sub-populations including cancer patients. It reminds us that the challenge remains to vaccinate the entire population of patients who have or have had cancer, i.e. approximately 3.8 million people.

The level of efficacy can be expected to be generally reduced in certain cancer patient populations with intense immunosuppression, such as haematopoietic stem cell transplant recipients. However, based on extrapolation of data from other vaccines and the mechanism of action of COVID-19 (non-live) vaccines, it is conceivable that the efficacy and safety of COVID-19 vaccination could be estimated to be similar to that of non-cancer patients, although data from clinical trials are lacking. The efficacy and duration of immunity in cancer patients is still unknown and unexplored. It is therefore legitimate to propose surveillance through dedicated registries and clinical trials. Furthermore, close monitoring and follow-up of cancer patients is required after COVID-19 vaccination to assess potential adverse events and measure clinical outcomes, e.g. infection, severity and mortality from COVID-19, cancer complications etc… The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. Our hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J \& J COVID-19 Vaccine.

Keywords
Cancer, Covid-19, Vaccination, Immunotherapy
Medical subject headings
Neoplasms, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05025514
Study groupRoleWhat they receive
Patients treated for cancer, vaccinated or eligible for anti-COVID vaccination.Patients undergoing treatment with anti-PD immunotherapy, anti-PDL1 or anti-CTLA4 immunotherapy for any tumour (solid, liquid) treated in the medical oncology departments of the Occitanie area. who have been vaccinated or who are eligible for inoculation with one of the available anti-COVID19 vaccines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    Measured: 24 hours after the vaccination

  2. Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    Measured: 48 hours after the vaccination

  3. Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    Measured: 8 days after the vaccination

  4. Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    Measured: 24 hours after the following vaccination

  5. Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    Measured: 48 hours after the following vaccination

  6. Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    Measured: 8 days after the following vaccination

  7. Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    Measured: 1 month after the following vaccination

  8. Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    Measured: 3 months after the following vaccination

  9. Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    Measured: 6 months after the following vaccination

Secondary outcomes (27)

  1. A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    Any adverse events related to the immunotherapy qualified as Grade ≥3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded.

    Measured: 24 hours after the vaccination

  2. A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    Any adverse events related to the immunotherapy qualified as Grade ≥3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded.

    Measured: 48 hours after the vaccination

  3. A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    Any adverse events related to the immunotherapy qualified as Grade ≥3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded.

    Measured: 8 days after the vaccination

  4. A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    Any adverse events related to the immunotherapy qualified as Grade ≥3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded.

    Measured: 24 hours after the following vaccination

  5. A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    Any adverse events related to the immunotherapy qualified as Grade ≥3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded.

    Measured: 48 hours after the following vaccination

  6. A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    Any adverse events related to the immunotherapy qualified as Grade ≥3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded.

    Measured: 1 month after the following vaccination

  7. A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    Any adverse events related to the immunotherapy qualified as Grade ≥3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded.

    Measured: 3 months after the following vaccination

  8. A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    Any adverse events related to the immunotherapy qualified as Grade ≥3 according to the Common Terminology Criteria for Adverse Events classification (NCI CTCAE V5.0) will be recorded.

    Measured: 6 months after the following vaccination

  9. B.Response to vaccine: dosage of anti-Spike antibodies (ELISA)

    Quantification of anti-Spike IgG by ELISA.

    Measured: Day 0

  10. B.Response to vaccine: dosage of anti-RBD antibodies (ELISA)

    Quantification of anti-RBD IgG by ELISA.

    Measured: Day 0

  11. B. Response to vaccine: Lymphocyte count by Quantiferon

    Lymphocytes will be measured in µg/ml

    Measured: Day 0

  12. B. Response to vaccine: dosage of anti-Spike antibodies (ELISA)

    Quantification of anti-Spike IgG by ELISA.

    Measured: 1 month after the injection

  13. B. Response to vaccine: dosage of anti-RBD antibodies (ELISA)

    Quantification of anti-RBD IgG by ELISA.

    Measured: 1 month after the injection

  14. B. Response to vaccine: Lymphocyte count by Quantiferon

    Lymphocytes will be measured in µg/ml

    Measured: 1 month after the injection

  15. B. Response to vaccine: dosage of anti-spike antibodies (ELISA)

    Quantification of anti-Spike IgG by ELISA.

    Measured: 1 month after the following injection

  16. B. Response to vaccine: dosage of anti-RBD antibodies (ELISA)

    Quantification of anti-RBD IgG by ELISA.

    Measured: 1 month after the following injection

  17. B. Response to vaccine: Lymphocyte count by Quantiferon

    Lymphocytes will be measured in µg/ml

    Measured: 1 month after the following injection

  18. B. Response to vaccine: dosage of anti-spike antibodies (ELISA)

    Quantification of anti-Spike IgG by ELISA.

    Measured: 3 months after the following injection

  19. B. Response to vaccine: dosage of anti-RBD antibodies (ELISA)

    Quantification of anti-RBD IgG by ELISA.

    Measured: 3 months after the following injection

  20. B. Response to vaccine: Lymphocyte count by Quantiferon

    Lymphocytes will be measured in µg/ml

    Measured: 3 months after the following injection

  21. B. Response to vaccine: dosage of anti-spike antibodies (ELISA)

    Quantification of anti-Spike IgG by ELISA .

    Measured: 6 months after the following injection

  22. B. Response to vaccine: dosage of anti-RBD antibodies (ELISA)

    Quantification of anti-RBD IgG by ELISA .

    Measured: 6 months after the following injection

  23. B. Response to vaccine: Lymphocyte count by Quantiferon

    Lymphocytes will be measured in µg/ml

    Measured: 6 months after the following injection

  24. C. Efficacy of vaccination against the incidence of COVID-19

    The efficacy of vaccination against the incidence of COVID-19 will be evaluated based on the main clinical symptoms noted and a PCR test. Qualitative: YES/NO

    Measured: 1 month after vaccination

  25. C. Efficacy of vaccination against the incidence of COVID-19

    The efficacy of vaccination against the incidence of COVID-19 will be evaluated based on the main clinical symptoms noted and a PCR test. Qualitative: YES/NO

    Measured: 3 months after vaccination

  26. C. Efficacy of vaccination against the incidence of COVID-19

    The efficacy of vaccination against the incidence of COVID-19 will be evaluated based on the main clinical symptoms noted and a PCR test. Qualitative: YES/NO

    Measured: 6 months after vaccination

  27. D. Constitution of a biobank

    Unused sample aliquots (tube bottoms) at the end of the tests will be kept; constitution of a serum library and an immune bank. Samples will be stored at -80°C (plasma) and -196°C (Peripheral Blood Mononuclear Cells) at the Biological Resource Centre at Nîmes University Hospital.

    Measured: Up to 6 months after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start19 Oct 2021
  3. Primary completion16 Sep 2022
  4. Study completion16 Sep 2022

Why it stopped: end of the COVID outbreak

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05025514
Sponsor's protocol ID
LOCAL COVID/2021/NH-001
Other IDs
2021-A01144-37
Acronym
IVACOV
Status last verified
Jun 2026
First submitted
25 Aug 2021
Last updated
22 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

    PubMed 33378609

  • Knoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. Epub 2020 Dec 8. No abstract available.

    PubMed 33306990

  • Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8.

    PubMed 33306989

  • Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.

    PubMed 33882225

  • Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

    PubMed 33301246

  • Anderson EJ, Rouphael NG, Widge AT, Jackson LA, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O'Dell S, Schmidt SD, Corbett KS, Swanson PA 2nd, Padilla M, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Martinez DR, Baric R, Buchanan W, Luke CJ, Phadke VK, Rostad CA, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. N Engl J Med. 2020 Dec 17;383(25):2427-2438. doi: 10.1056/NEJMoa2028436. Epub 2020 Sep 29.

    PubMed 32991794

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Immunotherapy, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.

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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: end of the COVID outbreak). Results are not available in the source record.

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?

Tolerance of immunotherapy following anti-COVID-19 vaccination (time frame: 24 hours after the vaccination). The study lists 9 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 NCT05025514, which also lists 6 linked publications.

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 22 Jun 2026.

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