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

NCT ID: NCT05025514

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2024-06-01

Brief 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" 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.

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.

Conditions

Cancer; Immunotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: collaborator

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: collaborator

Centre Hospitalier de Bagnols-sur-Cèze

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier du Bassin de Thau

UNKNOWN

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

Centre Hospitalier de Cahors

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier d'Auch

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Intercommunal de Castres

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier d'Albi

UNKNOWN

Sponsor Role: collaborator

Clinique Claude Bernard, Albi

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier de Bigorre - Tarbes

UNKNOWN

Sponsor Role: collaborator

Clinique La Croix du Sud Quint-Fonsegrives

UNKNOWN

Sponsor Role: collaborator

Clinique Les Cèdres Cornebarrieu

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Ales

UNKNOWN

Sponsor Role: collaborator

CENTRE HOSPITALIER COMMINGES PYRENEES

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadine HOUEDE, Professeur

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

Clinique Claude Bernard

Albi, , France

Site Status: RECRUITING

Centre Hospitalier d'Albi

Albi, , France

Site Status: RECRUITING

Centre Hospitalier d'Alès

Alès, , France

Site Status: RECRUITING

CH d'Auch

Auch, , France

Site Status: RECRUITING

CH de Bagnols sur Cèze

Bagnols-sur-Cèze, , France

Site Status: RECRUITING

CH de Cahors

Cahors, , France

Site Status: RECRUITING

Clinique des Cèdres - Capio

Cornebarrieu, , France

Site Status: RECRUITING

Institut de Cancer de Montpellier

Montpellier, , France

Site Status: RECRUITING

Clinique La Croix du Sud

Quint-Fonsegrives, , France

Site Status: RECRUITING

Centre Hospitalier COMMINGES PYRENEES

Saint-Gaudens, , France

Site Status: NOT_YET_RECRUITING

Centre Hospitalier du bassin de Thau

Sète, , France

Site Status: RECRUITING

CH de Bigorre

Tarbes, , France

Site Status: RECRUITING

Centre Hospitalier de Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Annissa MEZGARI

Role: CONTACT

drc@CHU-nimes.fr

+33 4.66.68.34.00

Facility Contacts

Role: primary

04 66 79 10 11

Jesus Diaz

Role: primary

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Other Identifiers

2021-A01144-37

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL COVID/2021/NH-001

Identifier Type: -

Identifier Source: org_study_id